Trial Outcomes & Findings for ENAC Blockade and Arterial Stiffness (NCT NCT03837626)
NCT ID: NCT03837626
Last Updated: 2025-12-30
Results Overview
cfPWV is the gold standard of arterial stiffness. It was assessd during experimental visits, under the same conditions in a blinded manner
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
137 participants
Primary outcome timeframe
baseline, 3 and 6 mo
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Amiloride
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
Placebo
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
47
|
|
Overall Study
COMPLETED
|
79
|
37
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Amiloride
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
Placebo
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
ENAC Blockade and Arterial Stiffness
Baseline characteristics by cohort
| Measure |
Amiloride
n=90 Participants
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
Total
n=137 Participants
Total of all reporting groups
|
Placebo
n=47 Participants
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
86 Participants
n=6 Participants
|
128 Participants
n=9 Participants
|
42 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=6 Participants
|
87 Participants
n=9 Participants
|
28 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=6 Participants
|
50 Participants
n=9 Participants
|
19 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=6 Participants
|
131 Participants
n=9 Participants
|
44 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=6 Participants
|
11 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=6 Participants
|
120 Participants
n=9 Participants
|
40 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=6 Participants
|
137 participants
n=9 Participants
|
47 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 and 6 moPopulation: Number of participants that finished clinical trial
cfPWV is the gold standard of arterial stiffness. It was assessd during experimental visits, under the same conditions in a blinded manner
Outcome measures
| Measure |
Placebo
n=37 Participants
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
Amiloride
n=97 Participants
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
|---|---|---|
|
Carotid Femoral Pulse Wave Velocity
3 months
|
7.25 m/s
Interval 6.85 to 7.65
|
6.80 m/s
Interval 6.53 to 7.07
|
|
Carotid Femoral Pulse Wave Velocity
6 months
|
7.12 m/s
Interval 6.73 to 7.51
|
6.81 m/s
Interval 6.54 to 7.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 6 moSystolic blood pressure obtained during experimental visits at the different time points
Outcome measures
| Measure |
Placebo
n=37 Participants
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
Amiloride
n=79 Participants
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
|---|---|---|
|
Systolic Blood Pressure
3 mo
|
127.53 mmHg
Interval 123.07 to 132.0
|
122.90 mmHg
Interval 119.85 to 125.94
|
|
Systolic Blood Pressure
6 mo
|
125.51 mmHg
Interval 121.11 to 129.92
|
120.27 mmHg
Interval 117.25 to 123.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months (interim) and 6 months (final)Brachial artery flow-mediated dilation will be assessed at baseline, 12, and 24 weeks. FMD is a measurement of conduit artery endothelial function.
Outcome measures
| Measure |
Placebo
n=32 Participants
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
Amiloride
n=70 Participants
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
|---|---|---|
|
Brachial Artery Flow Mediated Dilation (FMD)
3 months (interim)
|
6.03 Percentage
95% Confidence Interval 0.62 • Interval 4.9 to 7.17
|
6.25 Percentage
95% Confidence Interval 0.42 • Interval 5.49 to 7.02
|
|
Brachial Artery Flow Mediated Dilation (FMD)
Delta 6 months (final)
|
5.59 Percentage
95% Confidence Interval 0.56 • Interval 4.5 to 6.68
|
6.16 Percentage
95% Confidence Interval 0.44 • Interval 5.42 to 6.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months (interim) and 6 months (final)Popliteal artery flow-mediated dilation will be assessed at baseline, 12, and 24 weeks. FMD is a measurement of conduit artery endothelial function.
Outcome measures
| Measure |
Placebo
n=14 Participants
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
Amiloride
n=34 Participants
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
|---|---|---|
|
Popliteal Artery Flow Mediated Dilation (FMD)
3 months (interim)
|
1.71 Percentage
95% Confidence Interval 0.30 • Interval 0.74 to 2.69
|
2.22 Percentage
95% Confidence Interval 0.29 • Interval 1.59 to 2.84
|
|
Popliteal Artery Flow Mediated Dilation (FMD)
6 months (final)
|
1.80 Percentage
95% Confidence Interval 0.31 • Interval 0.91 to 2.69
|
2.55 Percentage
95% Confidence Interval 0.34 • Interval 2.02 to 3.09
|
Adverse Events
Amiloride
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amiloride
n=90 participants at risk
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill: Max dose of 5 mg a day for 6 months
|
Placebo
n=47 participants at risk
6 months of daily placebo
Placebo - Cap: 6 months of 1 pill a day
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
9/90 • Number of events 9 • 6 months
|
10.6%
5/47 • Number of events 5 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place