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Hormone Therapy

Angiotensin-(1-7) for Cardiovascular Health in Aging

Phase < 1

Recruiting

Led By Amy Arnold, PhD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 65-80 years

Normotensive defined as seated blood pressure <130/80 mmHg and without hypertensive medications

Must not have

Decisional impairment

History or presence of immunological or hematological disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 110 minutes

Summary

This trial will test whether angiotensin-(1-7), a hormone that protects against the renin-angiotensin system, can reduce the risk of cardiovascular disease in older adults by reducing sympathetic outflow and blood pressure and improving endothelial function.

Who is the study for?

This trial is for healthy older adults aged 65-80 with normal blood pressure and BMI between 18.5 and 30 kg/m2. Participants must be fluent in English, able to consent, not on certain medications or have conditions like impaired liver/renal function, anemia, diabetes, serious cardiovascular or cerebrovascular disease.

What is being tested?

The study investigates if angiotensin-(1-7), a hormone that could help the heart and blood vessels work better, can lower sympathetic nervous system activity and improve blood vessel function in aging individuals compared to saline (a placebo).

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions similar to those seen with ACE inhibitors or angiotensin receptor blockers since these drugs also increase angiotensin-(1-7) levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 65 and 80 years old.

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My blood pressure is below 130/80 mmHg without medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty making decisions due to a mental condition.

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I have a history of immune or blood disorders.

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I am taking medication that affects my nervous system.

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I have diabetes (type I or II) indicated by high fasting glucose or I'm on diabetes medication.

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I have been on steroids for more than a week in the last month.

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I am younger than 65 or older than 80.

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I have anemia.

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I have high blood pressure or a serious heart or brain blood vessel condition.

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I am allergic to or cannot take certain blood pressure medicines.

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I am currently taking blood thinners like warfarin.

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My liver tests (AST or ALT) are more than twice the normal limit.

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My kidney function is impaired with a creatinine level over 2.0 mg/dl.

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I am not pregnant, nursing, or on hormone replacement therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 110 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~110 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 110 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Muscle Sympathetic Nerve Burst Rate

Secondary study objectives

Change in Brachial Artery Diameter

Change in Heart Rate

Change in Heart Rate Variability

+5 more

Other study objectives

Change in Aldosterone

Change in Angiotensin II

Change in Angiotensin-(1-7)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Angiotensin-(1-7)Experimental Treatment1 Intervention

Participants will receive intravenous angiotensin-(1-7) at one study visit for 110 minutes. Angiotensin-(1-7) will be given in escalating doses of 2 ng/kg/min, 4 ng/kg/min, and 8 ng/kg/min. Each of these doses will be infused for 10 minutes. Following the dose escalation, angiotensin-(1-7) will be given at 8 ng/kg/min for an additional 80 minutes. Infusion rates will be calculated for each participant based on body mass.

Group II: SalinePlacebo Group1 Intervention

Participants will receive intravenous saline at one study visit for 110 minutes total. The volume of saline will match the volume of angiotensin-(1-7) infused. Infusion rates will be calculated for each participant based on body mass.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiotensin-(1-7)

2020

Completed Phase 2

~120

0 / 15Eligibility criteria met