Trial Outcomes & Findings for Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans (NCT NCT03179163)
NCT ID: NCT03179163
Last Updated: 2024-02-28
Results Overview
This measurement is performed using a laser Doppler flow meter. The flow meter produces a non-invasive qualitative and dimensionless index of blood flow in blood vessels during the localized perfusion of the endothelium-dependent vasodilatory acetycholine in a dose response fashion. The results are the differences in the area under the curve units=(laser Doppler flux/MAP)\*logAch concentration
TERMINATED
PHASE1/PHASE2
10 participants
16 weeks
2024-02-28
Participant Flow
All participants were recuited out of the Centre County region and had Stage II hypertension based on resting seated brachial blood pressure. Other than hypertension, all participants were clinically healthy.
Participant milestones
| Measure |
Hypertensive - ACEi +SH
Captopril Pill intervention Blood Pressure ≥140/90 mmHg and \<160/110 mmHg
Captopril Pill: ACEi+SH
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans
Baseline characteristics by cohort
| Measure |
Hypertensive - Sulfahydrdryl-donaging ACE Inhibitor
n=10 Participants
Captopril Pill intervention Blood Pressure ≥140/90 mmHg and \<160/110 mmHg
Captopril Pill 50-100 mg twice daily
|
|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThis measurement is performed using a laser Doppler flow meter. The flow meter produces a non-invasive qualitative and dimensionless index of blood flow in blood vessels during the localized perfusion of the endothelium-dependent vasodilatory acetycholine in a dose response fashion. The results are the differences in the area under the curve units=(laser Doppler flux/MAP)\*logAch concentration
Outcome measures
| Measure |
Hypertensive - ACEi +SH
n=10 Participants
Captopril Pill intervention Blood Pressure ≥140/90 mmHg and \<160/110 mmHg
Captopril Pill: ACEi+SH
|
|---|---|
|
Change in Endothelium Dependent Vasodilation
|
83 (flux/MAP)*logAch (mol/L)
Standard Deviation 47
|
SECONDARY outcome
Timeframe: 16 WeeksBlood pressure is measured via brachial auscultation manually or with a critical care monitor. The peak blood pressure during a cardiac cycle when the heart contracts.
Outcome measures
| Measure |
Hypertensive - ACEi +SH
n=10 Participants
Captopril Pill intervention Blood Pressure ≥140/90 mmHg and \<160/110 mmHg
Captopril Pill: ACEi+SH
|
|---|---|
|
Systolic Blood Pressure
|
122 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 16 WeeksBlood pressure is measured via brachial auscultation manually or with a critical care monitor. The lowest blood pressure during a cardiac cycle when the heart is between beats.
Outcome measures
| Measure |
Hypertensive - ACEi +SH
n=10 Participants
Captopril Pill intervention Blood Pressure ≥140/90 mmHg and \<160/110 mmHg
Captopril Pill: ACEi+SH
|
|---|---|
|
Diastolic Blood Pressure
|
80 mmHg
Standard Deviation 8
|
Adverse Events
Hypertensive - ACEi +SH
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place