Trial Outcomes & Findings for Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome (NCT NCT03170375)
NCT ID: NCT03170375
Last Updated: 2025-09-10
Results Overview
Phase 1 primary hypothesis: greater reduction in carotid-femoral pulse wave velocity with DASH diet in individuals with salt-sensitive blood pressure Change in velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Phase 1 of study, change between week 2 and week 4
Results posted on
2025-09-10
Participant Flow
Phase 1: Screening visit: Follow baseline diet for 2 weeks Excluded if patient couldn't wean from renin-angiotensin-aldosterone system (RAAS) inhibitors and diuretics without complications 2-week visit: follow DASH-SRD diet for 2 weeks 4-week visit: randomized into Arm 1 or 2 and begin phase II of study.
Participant milestones
| Measure |
Phase 1: 2-week Diet As Usual Then 2 Weeks of DASH/SRD Diet
Consented participants will have clinic BP measured at the screening visit and will enter a two-week usual diet period, during which antihypertensive medications, with the exception of calcium channel blockers, will be weaned off. During this time period, the participant will consume their usual diet. Following the usual diet period and the week 2 visit, participants will consume the DASH/SRD diet for 14 days each.
|
Motivational Interviewing + WHEELS-I
In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
Performance of WHEELS-I in promoting DASH/SRD adoption: Participants will receive the WHEELS-I electronically-delivered tailored messaging intervention in addition to motivational interviewing-based counseling.
|
Motivational Interviewing
Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
|
|---|---|---|---|
|
Phase 1 - 4 Weeks
STARTED
|
71
|
0
|
0
|
|
Phase 1 - 4 Weeks
COMPLETED
|
66
|
0
|
0
|
|
Phase 1 - 4 Weeks
NOT COMPLETED
|
5
|
0
|
0
|
|
Phase 2 - 6 Months
STARTED
|
0
|
28
|
38
|
|
Phase 2 - 6 Months
COMPLETED
|
0
|
25
|
36
|
|
Phase 2 - 6 Months
NOT COMPLETED
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Phase 1: 2-week Diet As Usual Then 2 Weeks of DASH/SRD Diet
Consented participants will have clinic BP measured at the screening visit and will enter a two-week usual diet period, during which antihypertensive medications, with the exception of calcium channel blockers, will be weaned off. During this time period, the participant will consume their usual diet. Following the usual diet period and the week 2 visit, participants will consume the DASH/SRD diet for 14 days each.
|
Motivational Interviewing + WHEELS-I
In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
Performance of WHEELS-I in promoting DASH/SRD adoption: Participants will receive the WHEELS-I electronically-delivered tailored messaging intervention in addition to motivational interviewing-based counseling.
|
Motivational Interviewing
Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
|
|---|---|---|---|
|
Phase 1 - 4 Weeks
Withdrawal by Subject
|
5
|
0
|
0
|
|
Phase 2 - 6 Months
Withdrawal by Subject
|
0
|
3
|
2
|
Baseline Characteristics
Data collected from Phase 1 and Phase 2 are reported in separate Rows
Baseline characteristics by cohort
| Measure |
Phase 1: 2-week Diet As Usual Then 2 Weeks of DASH/SRD Diet
n=71 Participants
This arm includes all participants who started Phase 1 of the study. Phase 1 took place prior to randomization into either the Motivational Interviewing or Motivational Interviewing + WHEELS-I arm.
|
Motivational Interviewing + WHEELS-I
n=28 Participants
In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
|
Motivational Interviewing
n=38 Participants
Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Phase 1
|
66 years
STANDARD_DEVIATION 8 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
66 years
STANDARD_DEVIATION 8 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Age, Continuous
Phase 2
|
—
|
64 years
STANDARD_DEVIATION 9 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
67 years
STANDARD_DEVIATION 8 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
66 years
STANDARD_DEVIATION 8 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Sex: Female, Male
Phase 1 · Female
|
11 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
11 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Sex: Female, Male
Phase 1 · Male
|
60 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
60 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Sex: Female, Male
Phase 2 · Female
|
—
|
3 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
7 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
10 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Sex: Female, Male
Phase 2 · Male
|
—
|
25 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
31 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
56 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Ethnicity (NIH/OMB)
Phase 1 · Hispanic or Latino
|
4 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
4 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Ethnicity (NIH/OMB)
Phase 1 · Not Hispanic or Latino
|
63 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
63 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Ethnicity (NIH/OMB)
Phase 1 · Unknown or Not Reported
|
4 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
4 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Ethnicity (NIH/OMB)
Phase 2 · Hispanic or Latino
|
—
|
3 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
3 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Ethnicity (NIH/OMB)
Phase 2 · Not Hispanic or Latino
|
—
|
23 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
36 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
59 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Ethnicity (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
—
|
2 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
2 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
4 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 1 · American Indian or Alaska Native
|
0 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
0 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 1 · Asian
|
1 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
1 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
0 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 1 · Black or African American
|
10 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
10 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 1 · White
|
57 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
57 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 1 · More than one race
|
0 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
0 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 1 · Unknown or Not Reported
|
3 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
3 Participants
n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 2 · American Indian or Alaska Native
|
—
|
0 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 2 · Asian
|
—
|
1 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
1 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 2 · Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 2 · Black or African American
|
—
|
2 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
8 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
10 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 2 · White
|
—
|
23 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
29 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
52 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 2 · More than one race
|
—
|
0 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
0 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Race (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
—
|
2 Participants
n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
1 Participants
n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
3 Participants
n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
BMI
Phase 1
|
34.4 kg/m^2
STANDARD_DEVIATION 5.1 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
34.4 kg/m^2
STANDARD_DEVIATION 5.1 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
BMI
Phase 2
|
—
|
34.7 kg/m^2
STANDARD_DEVIATION 4.7 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
34.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
34.5 kg/m^2
STANDARD_DEVIATION 5.1 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Waist Circumference
Phase 1
|
116 cm
STANDARD_DEVIATION 14 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
116 cm
STANDARD_DEVIATION 14 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Waist Circumference
Phase 2
|
—
|
117 cm
STANDARD_DEVIATION 9 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
116 cm
STANDARD_DEVIATION 17 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
116 cm
STANDARD_DEVIATION 14 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Hip Circumference
Phase 1
|
117 cm
STANDARD_DEVIATION 15 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
117 cm
STANDARD_DEVIATION 15 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Hip Circumference
Phase 2
|
—
|
118 cm
STANDARD_DEVIATION 11 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
116 cm
STANDARD_DEVIATION 17 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
117 cm
STANDARD_DEVIATION 15 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Systolic Blood Pressure
Phase 1
|
133 mmHg
STANDARD_DEVIATION 15 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
133 mmHg
STANDARD_DEVIATION 15 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Systolic Blood Pressure
Phase 2
|
—
|
136 mmHg
STANDARD_DEVIATION 14 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
132 mmHg
STANDARD_DEVIATION 16 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
134 mmHg
STANDARD_DEVIATION 15 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Diastolic Blood Pressure
Phase 1
|
72 mmHg
STANDARD_DEVIATION 11 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
72 mmHg
STANDARD_DEVIATION 11 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Diastolic Blood Pressure
Phase 2
|
—
|
74 mmHg
STANDARD_DEVIATION 11 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
72 mmHg
STANDARD_DEVIATION 11 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
73 mmHg
STANDARD_DEVIATION 11 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Triglycerides
Phase 1
|
163 mg/dL
STANDARD_DEVIATION 107 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
163 mg/dL
STANDARD_DEVIATION 107 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Triglycerides
Phase 2
|
—
|
157 mg/dL
STANDARD_DEVIATION 54 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
157 mg/dL
STANDARD_DEVIATION 131 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
157 mg/dL
STANDARD_DEVIATION 105 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
HDL Cholesterol
Phase 1
|
45 mg/dL
STANDARD_DEVIATION 10 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
45 mg/dL
STANDARD_DEVIATION 10 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
HDL Cholesterol
Phase 2
|
—
|
43 mg/dL
STANDARD_DEVIATION 9 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
46 mg/dL
STANDARD_DEVIATION 11 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
45 mg/dL
STANDARD_DEVIATION 10 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Hemoglobin A1c
Phase 1
|
6.2 %
STANDARD_DEVIATION 1.1 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
—
|
—
|
6.2 %
STANDARD_DEVIATION 1.1 • n=71 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
|
Hemoglobin A1c
Phase 2
|
—
|
6.3 %
STANDARD_DEVIATION 1.0 • n=28 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
6.3 %
STANDARD_DEVIATION 1.1 • n=38 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
6.3 %
STANDARD_DEVIATION 1.1 • n=66 Participants • Data collected from Phase 1 and Phase 2 are reported in separate Rows
|
PRIMARY outcome
Timeframe: Phase 1 of study, change between week 2 and week 4Phase 1 primary hypothesis: greater reduction in carotid-femoral pulse wave velocity with DASH diet in individuals with salt-sensitive blood pressure Change in velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Outcome measures
| Measure |
Salt-sensitive Participants
n=28 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=31 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Carotid-femoral Pulse Wave Velocity
|
-0.3 m/s
Standard Deviation 1.6
|
0.4 m/s
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsLeft ventricular mass indexed to body surface area. Larger/greater left ventricular mass index is associated with increased long-term risk of cardiovascular events, including the development of heart failure. Normal values for men are 49-115 g/m² and for women 43-95 g/m²
Outcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=35 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Left Ventricular Mass Index
|
-3.3 g/m2
Standard Deviation 15.5
|
-1.7 g/m2
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Phase 1 of study, change between week 2 to week 4Global longitudinal left ventricular strain (GLS), a sensitive measure of ventricular systolic function GLS is calculated by dividing the reduction in length of a myocardial (heart) segment from the end of diastole (maximum relaxation) to the end of systole (maximum contraction) by the segment's original length at end-diastole (i.e. change in length/original length). GLS is averaged across six myocardial segments, is expressed in a percentage, and is negative by convention since cardiac segment length decreases during systole. The more negative/greater magnitude, the better the GLS. Normal GLS is -18% to -22%. Low GLS is associated with long-term increased risk of cardiovascular events, including the development of heart failure.
Outcome measures
| Measure |
Salt-sensitive Participants
n=19 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=24 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Global Longitudinal Left Ventricular Strain
|
-0.2 ratio
Standard Deviation 2.5
|
-0.5 ratio
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsVelocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Outcome measures
| Measure |
Salt-sensitive Participants
n=23 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=34 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Carotid-femoral Pulse Wave Velocity
|
1.1 m/s
Standard Deviation 1.5
|
0.3 m/s
Standard Deviation 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 1 of study, change between week 2 and week 4Salt-sensitive blood pressure means that blood pressure changes more than 'normal' when dietary sodium intake changes, i.e. increases or decreases in parallel with sodium intake. Having a salt-sensitive blood pressure pattern is an independent long-term risk factor for cardiovascular events. Variable testing approaches, blood pressure thresholds, and methods of blood pressure measurement have been proposed in the literature to define blood pressure salt-sensitivity. In this study, we report "salt-sensitive" vs. "non salt-sensitive" as a binary variable. Change in 24-hour mean blood pressure of \>= 4 mmHg between the ad-lib and home-delivered meal periods of Phase 1 defines the salt-sensitive blood pressure phenotype
Outcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=38 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Salt-sensitivity Phenotype
|
9 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsMeasure of daily dietary sodium intake
Outcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=36 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
24-hour Urinary Sodium Excretion
|
-456 mg/24h
Standard Deviation 2077
|
-204 mg/24h
Standard Deviation 1721
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsSodium-restricted DASH diet score on FFQ, measured by quintiles of intake in 8 dietary domains as compared with age- and sex-matched norms from NHANES national US survey data. Score ranges 8-40 points, with higher scores indicating greater adherence
Outcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=36 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Sodium-restricted DASH Diet Adherence by Food Frequency Questionnaire (FFQ)
|
1.5 points
Standard Deviation 3.1
|
1.4 points
Standard Deviation 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsAnalysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research. DASH diet adherence score based on proportion of recommended daily intake in 9 domains, score ranges 0-9 points with higher scores indicating greater adherence
Outcome measures
| Measure |
Salt-sensitive Participants
n=23 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=35 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Sodium-restricted DASH Diet Adherence
|
0.3 points
Standard Deviation 1.3
|
0.6 points
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsChange in systolic blood pressure obtained in clinic with automated brachial cuff
Outcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=36 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Clinic Systolic Blood Pressure
|
-5.4 mmHg
Standard Deviation 12.9
|
-4.1 mmHg
Standard Deviation 15.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsOutcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=36 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Clinic Diastolic Blood Pressure
|
-3.2 mmHg
Standard Deviation 10.7
|
-3.5 mmHg
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsSerum triglyceride changes during dietary intervention
Outcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=36 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Triglycerides
|
41 mg/dL
Standard Deviation 39
|
39 mg/dL
Standard Deviation 127
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 of study, change from baseline to 6 monthsUnitless ratio of urine sodium (in mmol) divided by urine potassium (in mmol), measured from spot samples taken from 24-hour urine samples.
Outcome measures
| Measure |
Salt-sensitive Participants
n=25 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
Non Salt-sensitive Participants
n=36 Participants
Participants are defined as having a salt-sensitive blood pressure phenotype if they have \>= 4 mmHg change in mean arterial pressure by 24-hour monitoring between baseline and low-sodium diet conditions
|
|---|---|---|
|
Urine Sodium and Potassium Ratios
|
-1.2 ratio
Standard Deviation 1.1
|
-1.2 ratio
Standard Deviation 1.2
|
Adverse Events
Motivational Interviewing + WHEELS-I
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Interviewing
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Motivational Interviewing + WHEELS-I
n=28 participants at risk
In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan, participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
|
Motivational Interviewing
n=38 participants at risk
Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/28 • Baseline to end of study, an average of 1 year
|
2.6%
1/38 • Baseline to end of study, an average of 1 year
|
|
Surgical and medical procedures
Lobectomy
|
0.00%
0/28 • Baseline to end of study, an average of 1 year
|
2.6%
1/38 • Baseline to end of study, an average of 1 year
|
|
Infections and infestations
Tooth infection
|
3.6%
1/28 • Baseline to end of study, an average of 1 year
|
0.00%
0/38 • Baseline to end of study, an average of 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place