Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans (H2SPharm)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03179163|
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : June 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension,Essential||Drug: Captopril Pill Drug: Enalapril Pill Drug: Hydrochlorothiazide||Phase 1 Phase 2|
Upon initial screening and again within a week of testing, all subjects will have an assessment of 24-hour ambulatory blood pressure. Subject screening will be performed by the Penn State Clinical Translational Research Center (CTRC) medical staff and will include a physical exam by a clinician, anthropometry, and a chemical and lipid profile, liver and renal function. Women will be either postmenopausal (absence of menstruation of >1 year and Follicle Stimulating Hormone (FSH) >25 milli-international units per milliliter (mlU/ml)) and not be taking hormone replacement therapy, or normally menstruating and tested in the early follicular phase of their cycle. Subjects will also go through an assessment of conduit vessel endothelial and vascular smooth muscle function with brachial artery flow-mediated vasodilation (FMD), and sublingual nitroglycerin.
Subjects will undergo initial microdialysis experiments and biopsy samples will be obtained. Subjects will then be randomly assigned to treatment group. Blood pressure will be monitored every 2 weeks and weekly compliance checks will be made by the researcher's nurse coordinator. 24-hour ambulatory blood pressure monitoring will be conducted monthly to determine the efficacy of antihypertensive treatment and to inform dosing titration. Examining pharmacokinetic and dynamic data from the literature indicate that blood pressure lowing and peripheral vascular effects are maximized by 12 weeks of antihypertensive therapy and maintained thereafter. After 16 weeks of the assigned intervention, subjects will repeat microdialysis experiments and additional cutaneous biopsy samples will be obtained. Conduit artery measures including brachial artery FMD and responsiveness to sublingual nitroglycerin will also be evaluated at this time.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects are grouped as normal (<120/80 mmHg) and hypertensive (≥140/90 mmHg and <160/110 mmHg). All subjects undergo one round of experiments. Hypertensive subjects received randomly-assigned antihypertension medication (ACEi+SH, ACEi, or diuretic) for 16 weeks and then repeat experiments. Normotensive subjects receive no intervention and repeat experiments16 weeks after initial experiments as a time control.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Investigator and Outcomes Assessor are masked according to treatment.|
|Primary Purpose:||Basic Science|
|Official Title:||Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvascular Function and Vessel Remodeling in Hypertensive Humans|
|Actual Study Start Date :||July 20, 2016|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
No Intervention: Normotensive
Blood Pressure <120/80 mmHg
Experimental: Hypertensive - ACEi +SH
Captopril Pill intervention Blood Pressure ≥140/90 mmHg and <160/110 mmHg
Drug: Captopril Pill
Other Name: National Drug Code (NDC) # 00781-8061-01
Experimental: Hypertensive - ACE inhibitor (ACEi)
Enalapril Pill intervention Blood Pressure ≥140/90 mmHg and <160/110 mmHg
Drug: Enalapril Pill
Other Name: NDC# 51672-4039-03
Active Comparator: Hypertensive - Diuretic
Hydrochlorothiazide intervention Blood Pressure ≥140/90 mmHg and <160/110 mmHg
Other Name: NDC# 00603-3857-32
- laser Doppler blood flow [ Time Frame: 16 weeks ]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.
- Systolic Blood Pressure [ Time Frame: 16 Weeks ]Blood 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.
- Diastolic Blood Pressure [ Time Frame: 16 Weeks ]Blood 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179163
|Contact: Susan K Slimak, RNemail@example.com|
|Contact: Sean W Shank, BSfirstname.lastname@example.org|
|United States, Pennsylvania|
|Pennsylvania State University||Recruiting|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||Lacy M Alexander, PhD||Penn State University|