Investigating nerve activity's role in blood vessel stiffness in older adults with hypertension

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

This study is testing whether a medication that affects nerve activity can help reduce stiffness in the arteries of older adults with high blood pressure.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: University of Iowa (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Iowa City, Iowa and 1 other locations)
• Trial ID: NCT04423627 on ClinicalTrials.gov

What this trial studies

This study aims to explore the relationship between nerve activity from the brain and the stiffness of large arteries, particularly in older adults with isolated systolic hypertension. Participants aged 60-85 will receive either clonidine, hydrochlorothiazide, or a placebo to assess the impact on arterial stiffness. The research seeks to determine if targeting nerve activity could provide a new therapeutic approach to reduce stiffness in the aorta and carotid arteries, which is a significant risk factor for cardiovascular disease. The study will involve a washout period for those on antihypertensive medications to ensure accurate results.

Who should consider this trial

Good fit: Ideal candidates are clinically healthy adults aged 60-85 with untreated or treated stage 1 or stage 2 isolated systolic hypertension.

Not a fit: Patients with a history of cardiovascular disease, pulmonary disease, liver disease, diabetes, cancer, or psychiatric illness may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatments that effectively lower arterial stiffness and reduce the risk of cardiovascular diseases in older adults.

How similar studies have performed: While the specific approach of targeting nerve activity for arterial stiffness is novel, similar studies have shown promise in understanding cardiovascular health in older populations.

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.

Where this trial is running

Iowa City, Iowa and 1 other locations

• Amy Stroud — Iowa City, Iowa, United States (Recruiting)
• University of Iowa — Iowa City, Iowa, United States (Recruiting)

Study contacts

• Principal investigator: Gary Pierce, PhD — University of Iowa
• Study coordinator: Amy Stroud, RN, MSN

Conditions Hypertension, Systolic; Stiffness, Aortic