Sympathetic Regulation of Large Artery Stiffness in Humans With ISH

Hypertension, Systolic Clinical Trial

— SELECT  

Official title:

Sympathetic Regulation of Large Artery Stiffness in Humans With Age-Related Isolated Systolic Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423627
• Other study ID #: 202004244
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: University of Iowa
• Contact: Amy Stroud, RN, MSN
• Phone: 3193849549
• Email: amy-stroud[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Systolic
• Isolated Systolic Hypertension
• Stiffness, Aortic
• Systolic Murmurs

Intervention

Drug:
• Clonidine
Clonidine 0.2 mg/day oral tablet
• Hydrochlorothiazide
Hydrochlorothiazide 37.5 mg/day oral tablet
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Amy Stroud	Iowa City	Iowa
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in carotid-femoral pulse wave velocity	Aortic stiffness	Baseline and after 4 weeks
Secondary	Change in carotid distensibility index	Change in carotid distensibility	Baseline and after 4 weeks
Secondary	Change in carotid flow pulsatility index	Change in carotid flow pulsatility	Baseline and after 4 weeks
Secondary	Change in carotid intimal medial thickness (IMT)	Change in carotid wall thickness	Baseline and after 4 weeks