Status:
COMPLETED
Sympathetic Regulation of Large Artery Stiffness in Humans With ISH
Lead Sponsor:
University of Iowa
Conditions:
Hypertension, Systolic
Stiffness, Aortic
Eligibility:
All Genders
60-85 years
Phase:
EARLY_PHASE1
Brief Summary
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 at...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04423627
Start Date
June 1 2021
End Date
July 31 2025
Last Update
August 8 2025
Active Locations (2)
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1
Amy Stroud
Iowa City, Iowa, United States, 52240
2
University of Iowa
Iowa City, Iowa, United States, 52242