Sympathetic Regulation of Large Artery Stiffness in Humans With ISH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-07-31

Brief Summary

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Stiffening of your blood vessels, particularly the large vessels from your heart (called the aorta and carotids) you age contributes to the development of cardiovascular disease (CVD) such as heart attack and stroke. Nerve activity from your brain to your body also increases with advancing age but it is unknown if this nerve activity contributes directly to the stiffening on your blood vessels in older adults in addition to high blood pressure. Therefore, successful completion of the proposed aims will have a significant clinical impact by identifying if nerve activity from your brain could be a novel target for therapies that would lower stiffness of the aorta and carotid arteries in older adults.

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Detailed Description

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Conditions

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Hypertension, Systolic Stiffness, Aortic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo controlled, parallel design

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Clonidine

0.2 mg/day oral

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Clonidine 0.2 mg/day oral tablet

Hydrochlorothiazide

37.5 mg/day oral

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 37.5 mg/day oral tablet

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Clonidine

Clonidine 0.2 mg/day oral tablet

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide 37.5 mg/day oral tablet

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 60-85
* non-smoking
* clinically healthy
* untreated or treated stage 1 isolated systolic hypertension (ISH) (systolic BP 130-139 mmHg; diastolic BP \<90 mmHg) or stage 2 ISH (systolic BP 140-159 mmHg; diastolic BP \<90 mmHg) per 2017 AHA/ACC hypertension guidelines
* if subject is on antihypertensive medications, they will stop taking medication for a one-week washout period after Visit 1 before they return for Visit 2. They will come in at day 3 and day 7 of the one-week washout for a BP reading, to confirm that systolic BP is \<160 mmHg.

Exclusion Criteria

* no history of cardiovascular disease (e.g., myocardial infarction, bypass surgery, angioplasty/stent, heart failure, cardiomyopathy, pacemaker/defibrillator, peripheral artery disease), pulmonary disease, liver disease, Type I or II diabetes, cancer (treated by chemotherapy and/or radiation), psychiatric illness, on aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
* aspirin, NSAIDs, vitamins, herbal supplements, omega-3-fatty acids will have to discontinue for at least 1 week before participation and remain discontinued during the study.
* blood thinners, serotonin reuptake inhibitors (SSRIs), or PDE5 inhibitors will also be excluded.
* Women must be postmenopausal for at least 6 months (surgical or natural) and not currently on hormone replacement therapy.
* Subjects not on antihypertensive will not be eligible if their resting clinic systolic BP is \<130 mmHg or \>160 mmHg and diastolic BP \>90 mmHg.

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes