Trial Outcomes & Findings for Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis (NCT NCT06764277)
NCT ID: NCT06764277
Last Updated: 2026-02-03
Results Overview
Cardiac output (systolic volume x heart rate) was determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
COMPLETED
32 participants
Each participant was studied once 1-3 hours after dialysis ended
2026-02-03
Participant Flow
Participant milestones
| Measure |
Group A (ABP < 130/80 mmHg)
Constituted by15 patients in the chronic hemodialisis program with ABP \< 130/80 mmHg, and we measured interdialytic weight gain, cardiac output, systemic vascular resistance, blood pressure changes, interdialytic ambulatory blood pressure monitoring (ABPM) . Serum levels of angiotensin II, norepinephrin, copeptin and the ratio of monocytes + neutrophils / linphocytes (MNLR)
|
Group B (ABP 130-139/80-89 mmHg)
This group was constituted by patients with ABP 130-139/80-89 mmHg. They were 7 patients in the chronic hemodialisis program, and we measured blood pressure changes, interdialysis ambulatory blood pressure monitoring (ABPM) and interdialisis weight gain. Serum levels of angiotensin II, norepinephrin, copeptin and the ratio of monocytes + neutrophils / lymphocytes (MNLR).
|
Group C (ABP ≥ 140/90 mmHg)
Constituted by 10 patients in the chronic hemodialisis program, with ABP ≥ 140/90 mmHg. We measured blood pressure changes, interdialysis ambulatory blood pressure monitoring (ABPM) and interdialisis weight gain. Serum levels of angiotensin II, norepinephrin, copeptin, and the ratio of monocytes + neutrophils / linphocytes (MNLR)
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|---|---|---|---|
|
Overall Study
STARTED
|
15
|
7
|
10
|
|
Overall Study
COMPLETED
|
15
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A (ABP < 130/80 mmHg)
n=15 Participants
We observed 15 patients in the chronic hemodialysis program with ABP \< 130/80 mmHg, and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring and interdialytic weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, and the ratio of monocytes + neutrophils / lymphocytes (MNLR).
|
Group B (ABP 130-139/80-89 mmHg)
n=7 Participants
We observed 7 patients in the chronic hemodialysis program with ABP 130-139/80-89 mmHg , and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring and interdialysis weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, and the ratio of monocytes + neutrophils / lymphocytes (MNLR).
|
Group C (ABP ≥ 140/90 mmHg)
n=10 Participants
We observed 10 patients in the chronic hemodialysis program with ABP ≥ 140/90 mmHg and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring and interdialytic weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, and the ratio of monocytes + neutrophils / lymphocytes (MNLR).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
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Age, Continuous
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38 years
n=15 Participants
|
44 years
n=7 Participants
|
35 years
n=10 Participants
|
39 years
n=32 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=15 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=15 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=10 Participants
|
13 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
15 participants
n=15 Participants
|
7 participants
n=7 Participants
|
10 participants
n=10 Participants
|
32 participants
n=32 Participants
|
|
Cardiac output
|
3.88 L/min
STANDARD_DEVIATION 0.99 • n=15 Participants
|
4.10 L/min
STANDARD_DEVIATION 0.77 • n=7 Participants
|
4.55 L/min
STANDARD_DEVIATION 1.21 • n=10 Participants
|
4.25 L/min
STANDARD_DEVIATION 0.34 • n=32 Participants
|
|
Hypertension Phenotypes
Dippers
|
5 Participants
n=15 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
3 Participants
n=7 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
1 Participants
n=10 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
9 Participants
n=32 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
|
Hypertension Phenotypes
Non-dippers
|
5 Participants
n=15 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
2 Participants
n=7 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
4 Participants
n=10 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
11 Participants
n=32 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
|
Hypertension Phenotypes
Extreme Dippers
|
1 Participants
n=15 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
0 Participants
n=7 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
0 Participants
n=10 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
1 Participants
n=32 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
|
Hypertension Phenotypes
Reverse-dippers
|
4 Participants
n=15 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
2 Participants
n=7 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
5 Participants
n=10 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
11 Participants
n=32 Participants • Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32
|
PRIMARY outcome
Timeframe: Each participant was studied once 1-3 hours after dialysis endedPopulation: Patients were mexicans of both sexes of mixed (undetermined) race and ethnicity
Cardiac output (systolic volume x heart rate) was determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
Outcome measures
| Measure |
Group C
n=10 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=15 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=7 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Cardiac Output
|
4.6 L/min
Standard Error 0.38
|
3.9 L/min
Standard Error 0.26
|
4.10 L/min
Standard Error 0.29
|
—
|
PRIMARY outcome
Timeframe: Interdialytic weight change was studied once, by the difference between the weight at the end of dialysis and the weight 2-3 days later, before the next dialysis.Population: Patients were mexicans of both sexes and mixed (undetermined) race and ethnicity
The weight was determined in 2 ocassions: first, immediately after dialysis and second, 2-3 days later, before the next dialysis. The weight change in this interval is expressed as percentage change of the second measure in relation to the first measure.
Outcome measures
| Measure |
Group C
n=10 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=15 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=7 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Interdialytic Weight Change
|
2.98 percentage change
Standard Error 0.53
|
2.90 percentage change
Standard Error 0.37
|
3.22 percentage change
Standard Error 0.63
|
—
|
PRIMARY outcome
Timeframe: Systemic vascular resistance was determined once in the participants 1-3 hours after dialysisPopulation: All the participants were mexicans of both sexes and mixed (undetermined) race and ethnicity
Systemic vascular resistance was calculated using MediCalcR using the mean arterial pressure (MAP), the central venous pressure (CVP) anf the cardiac output (CO) and the equation: SVR=\[(MAP-CVP)x79.92\]/CO. Cardiac output (CO= systolic volume x heart rate) and central venous pressure were determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer. Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area.
Outcome measures
| Measure |
Group C
n=10 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=15 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=7 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Systemic Vascular Resistance
|
1751 dynes*s/cm˄5
Standard Error 187
|
1513 dynes*s/cm˄5
Standard Error 114.6
|
2045 dynes*s/cm˄5
Standard Error 161.0
|
—
|
SECONDARY outcome
Timeframe: Each participant was studied once. Serum samples taken before dialysisPopulation: The participants were mexican of both sexes and mixed (undetermined) race and ethnicity
Angiotensin serum levels (pg/ml) were determined once at the end of the interdialytic period, before dialysis, using ELISA (my BioSource Cat.# MBS703599)
Outcome measures
| Measure |
Group C
n=10 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=15 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=7 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Angiotensin II Serum Levels
|
231.5 pg/ml
Standard Error 40.4
|
105.3 pg/ml
Standard Error 12.9
|
158.3 pg/ml
Standard Error 43.8
|
—
|
SECONDARY outcome
Timeframe: Each participant was studied once. Blood samples taken before dialysis (following the end of the interdialytic period).Population: Participants were mexicans of mixed (undetermined) race
Monocyte+Neutrophile/lymphocyte ratio obtained from peripheral blood counts in samples taken before dialysis (following the end of the interdialytic period).
Outcome measures
| Measure |
Group C
n=10 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=15 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=7 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Monocyte+Neutrophiles/Lymphocyte Ratio (MNLR)
|
1.11 ratio
Standard Error 0.13
|
0.88 ratio
Standard Error 0.13
|
0.73 ratio
Standard Error 0.09
|
—
|
SECONDARY outcome
Timeframe: Each participant was studied once. Serum samples taken before dialysisPopulation: The studies were done at the end of the interdialytic period. Samples taken before the next dialysis
Interdialytic serum norepinephrine levels determined in blood samples obtained before dialysis (end of interdialytic period) using ELISA (ABCAM, Cat. # AB287789);
Outcome measures
| Measure |
Group C
n=10 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=15 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=7 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Serum Norepinephrine Levels
|
82.6 pg/ml
Interval 74.9 to 259.0
|
81.4 pg/ml
Interval 68.5 to 87.4
|
82.4 pg/ml
Interval 66.5 to 165.4
|
—
|
SECONDARY outcome
Timeframe: Each participant was studied once. Serum samples taken before dialysisPopulation: Mexican mixed population of undetermined race
The copeptin levels (surrogate for arginine vasopressin) were measured before dialyisis (end of the interdialytic period) using ELISA (Bio-techne/NovusBiological, Cat, # NBP2-69822)
Outcome measures
| Measure |
Group C
n=9 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=11 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=6 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Serum Copeptin Levels
|
13.0 pmol/L
Standard Error 1.56
|
14.6 pmol/L
Standard Error 1.09
|
10.3 pmol/L
Standard Error 0.92
|
—
|
SECONDARY outcome
Timeframe: Each participant was studied once. Ambulatory blood pressure was monitored or 24-44 hours during the interdialytic perdiod starting 1-3 hours after dialysisPopulation: The number of dippers, non-dippers, extreme dippers and reverse dippers were studied in all participants (n=32) .
Interdialytic ambulatory blood pressure determined during 24-44 hours using Space Labs Health Care, model 90217A and Contec ABPM50 equipment. Determinations every 30 minutes during daytime and every hour during the night. We are here reporting the phenotypes in the total number of participants (n=32) instead that in each group (groups A n=15, B n=7 and C n=10) because our main interest was to determine the incidence of each phenotyte in stable patients treated with chronic dialysis, rather than in each group that, individually, had few patients
Outcome measures
| Measure |
Group C
n=32 Participants
onstituted by 10 patients with ≥140/90 mmHg
|
Group A
n=32 Participants
Constituted by 15 patients with ABP \<130/80.
|
Group B
n=32 Participants
Constituted by 7 patients with ABP 130-139 mmHg.
|
Reverse Dipper
n=32 Participants
Nocturnal blood pressure higher than diurnal blood pressure
|
|---|---|---|---|---|
|
Hypertension Phenotypes
|
13 Participants
|
8 Participants
|
1 Participants
|
10 Participants
|
Adverse Events
Group 1 (TA < 130mmHg)
Group 2 (TA 130-139mmHg)
Group 3 (TA > 140)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bernardo Rodriguez Iturbe
Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran"
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place