Effects of angiotensin-(1-7) on heart health in older adults
Angiotensin-(1-7) Cardiovascular Effects in Aging
This study is testing if a hormone called angiotensin-(1-7) can help protect heart health by improving blood pressure and blood vessel function in healthy older adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05301192 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of angiotensin-(1-7), a hormone that may protect against cardiovascular issues, on blood pressure and blood vessel function in healthy older adults aged 65-80. It employs a randomized, double-blind, placebo-controlled, crossover design, where participants will receive either angiotensin-(1-7) or saline during two separate visits. The study will measure cardiovascular sympathetic tone, blood pressure, and endothelial function through various assessments, including blood samples and nerve activity monitoring. The goal is to understand if this treatment can mitigate age-related cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 65-80 with normal blood pressure and no history of cardiovascular disease.
Not a fit: Patients younger than 65 or older than 80, those with hypertension, or significant cardiovascular conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for reducing cardiovascular risks in older adults.
How similar studies have performed: While the specific approach of using angiotensin-(1-7) in this context is novel, related studies have shown promise in targeting the renin-angiotensin system for cardiovascular health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women of all races and ethnicities * Capable of giving informed consent * Fluent in written and spoken English * Age 65-80 years * Body mass index (BMI) between 18.5 and 30 kg/m2 * Normotensive defined as seated blood pressure \<130/80 mmHg and without hypertensive medications * Satisfactory history and physical exam Exclusion Criteria: * Age \< 65 or \> 80 years * Women who are pregnant, nursing, or taking hormone replacement therapy * Decisional impairment * Prisoners * Current or recent (less than 6 months) recreational drug history or excessive alcohol abuse history (greater than 14 drinks per week) * Current smokers * Highly trained athletes * Evidence of type I or type II diabetes (fasting glucose \> 126 mg/dL or use of anti-diabetic medications) * Hypertension or history of serious cardiovascular disease (e.g., myocardial infarction within 6 months, symptomatic coronary artery disease, presence of angina pectoris, significant arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy) or cerebrovascular disease (e.g., cerebral hemorrhage, stroke, transient ischemic attack). * History or presence of immunological or hematological disorders * Impaired hepatic function \[aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \>2 times upper limit of normal range\] * Impaired renal function (serum creatinine \>2.0 mg/dl) * Anemia * Taking drugs known to influence sympathetic activity (e.g. serotonin-norepinephrine reuptake inhibitors, norepinephrine transporter inhibitors, stimulants). * Treatment with anticoagulants (e.g. warfarin) * Treatment with chronic systemic glucocorticoid therapy (\>7 consecutive days in 1 month in the 1-month preceding the study) * Treatment with any investigational drug in the 1-month preceding the study * Known allergy or contraindication to angiotensin converting enzyme inhibitors or angiotensin receptor blockers, both of which increase endogenous angiotensin-(1-7) levels as part of their mechanism of action * Inability to give, or withdraw, informed consent
Where this trial is running
Hershey, Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Amy Arnold, PhD — Pennsylvania State University College of Medicine
- Study coordinator: Aimee Cauffman, RN
- Email: acauffman@pennstatehealth.psu.edu
- Phone: 717-531-1617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.