Sympathetic Regulation of Large Artery Stiffness in Humans With ISH
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.
Conditions:
🦠 Hypertension, Systolic 🦠 Stiffness, Aortic
🗓️ Study Start (Actual) 1 June 2021
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 December 2025
👥 Enrollment (Estimated) 78
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Iowa City, Iowa, United States
📍 Iowa City, Iowa, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 60 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 June 2020
  • First Submitted that Met QC Criteria 8 June 2020
  • First Posted 9 June 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 April 2024
  • Last Update Posted 19 April 2024
  • Last Verified April 2024