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Peptide

Angiotensin-(1-7) for Obesity and High Blood Pressure

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 18 to 60 years

Hypertension defined as two or more seated blood pressure readings >130/80 mmHg or use of antihypertensive medications

Must not have

Age ≤ 17 or ≥ 61 years

Secondary causes of hypertension (e.g., pheochromocytoma, primary aldosteronism, aortic coarctation, adrenal disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

Summary

This trial aims to investigate whether a new drug called angiotensin-(1-7) can help improve heart health in individuals who are obese and have high blood pressure, as obesity is linked to

Who is the study for?

This trial is for individuals who are dealing with obesity and high blood pressure, aiming to explore if angiotensin-(1-7) can enhance heart health. Specific eligibility details are not provided.

What is being tested?

The study investigates the cardiovascular effects of angiotensin-(1-7) compared to saline (a placebo), in people with obesity-related hypertension.

What are the potential side effects?

Potential side effects of angiotensin-(1-7) aren't detailed here, but typically could include changes in blood pressure, dizziness, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 60 years old.

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I have high blood pressure or am taking medication for it.

Exclusion Criteria

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

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I am either 17 years old or younger, or 61 years old or older.

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I do not have a specific condition causing high blood pressure.

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I have difficulty making decisions due to a mental condition.

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My kidney function is impaired with high creatinine levels.

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I have anemia.

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I am currently taking medication that affects my adrenaline levels.

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I am currently taking medication for erectile dysfunction.

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I am currently taking blood thinners like warfarin.

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I am unable to understand or decide about the clinical trial consent.

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

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My BMI is over 40.

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

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I am taking more than two medications for high blood pressure.

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I have diabetes based on my fasting glucose levels or because I take diabetes medication.

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I have a history of immune or blood disorders.

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I have had serious heart or stroke-related health issues recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 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 Brachial Artery Diameter

Change in Muscle Sympathetic Nerve Burst Rate

Secondary study objectives

Change in Diastolic Blood Pressure

Change in Heart Rate

Change in Muscle Sympathetic Nerve Amplitude

+4 more

Other study objectives

Change in Aldosterone

Change in Angiotensin II

Change in Angiotensin-(1-7)

+3 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 a total of 120 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 this 30 minute dose escalation period, angiotensin-(1-7) will be given at 8 ng/kg/min for an additional 90 minutes. Infusion rates will be calculated for each patient based on body mass.

Group II: SalinePlacebo Group1 Intervention

Participants receive intravenous saline at one study visit for a total of 120 minutes. The volume of saline will match the volume of angiotensin-(1-7) infused. Infusion rates will be calculated for each patient 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 / 18Eligibility criteria met