Clinical trial NCT04423627: Sympathetic Regulation of Large Artery Stiffness in Humans With ISH
Official title: Sympathetic Regulation of Large Artery Stiffness in Humans With Age-Related Isolated Systolic Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hypertension, Systolic
Stiffness, Aortic
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled, parallel design
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in carotid-femoral pulse wave velocity
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: Change in carotid distensibility index
timeFrame: Baseline and after 4 weeks
measure: Change in carotid flow pulsatility index
timeFrame: Baseline and after 4 weeks
measure: Change in carotid intimal medial thickness (IMT)
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Amy Stroud
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Gary Pierce, PhD
role: PRINCIPAL_INVESTIGATOR
References: