What side effects are associated with this type of intervention?

Common treatments for high blood pressure, such as ACE inhibitors (e.g., captopril, enalapril) and ARBs (e.g., valsartan), are generally well-tolerated but can have side effects. ACE inhibitors may cause cough, dizziness, rash, dysgeusia (altered taste), and, less frequently, proteinuria, neutropenia, and symptomatic hypotension. ARBs are typically associated with fewer side effects but can still cause dizziness and hyperkalemia. Both classes of drugs are effective in managing blood pressure and improving cardiovascular outcomes.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of high blood pressure that target the renin-angiotensin system, similar to the vasodilatory peptide Angiotensin (1-7). These include ACE inhibitors like enalapril and captopril, which help relax blood vessels and reduce blood pressure. Additionally, ARBs such as valsartan and losartan have been approved, offering an alternative mechanism to block the effects of angiotensin II, thereby lowering blood pressure. These medications have been shown to be effective in various clinical trials and are widely used in the management of hypertension.

What other types of research exist?

Promising, novel alternatives to Angiotensin (1-7) infusion for high blood pressure patients include renin-angiotensin system (RAS) blockers such as ACE inhibitors and ARBs, as well as newer classes of antihypertensive agents like sodium-glucose co-transporter 2 inhibitors (SGLT2-i) and glucagon-like peptide-1 receptor agonists (GLP1-RA). These therapies not only manage hypertension effectively but also offer additional cardiovascular benefits.

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Vasodilatory Peptide

Angiotensin (1-7) for High Blood Pressure

Phase 1

Waitlist Available

Led By Italo Biaggioni, MD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline in hemodynamic measures over the 50-minute infusion period

Awards & highlights

Summary

This trial is testing a substance given through an IV to see if it can help lower blood pressure in patients with high blood pressure that doesn't respond well to typical treatments. The study will also examine how the body's natural blood pressure control system affects the treatment's effectiveness.

Who is the study for?

This trial is for men and women aged 18-60 with high blood pressure (readings >130/85 mmHg), including those with pre-hypertension. Participants must be able to consent and not have a history of serious cardiovascular or cerebrovascular disease, immunological/hematological disorders, heavy smoking, drug/alcohol abuse, diabetes, liver issues, or be pregnant/breastfeeding.

What is being tested?

The study aims to understand the effects of Angiotensin (1-7) on hypertension by observing its impact when baroreflex buffering is intact versus eliminated using Trimethaphan. It also examines how Phenylephrine affects this process in individuals with essential hypertension.

What are the potential side effects?

Potential side effects may include changes in blood pressure levels due to the vasodilatory effect of Angiotensin (1-7), possible reflexive responses from baroreceptor manipulation by Trimethaphan, and reactions like headaches or increased heart rate from Phenylephrine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline in hemodynamic measures over the 50-minute infusion period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline in hemodynamic measures over the 50-minute infusion period

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in hemodynamic measures over the 50-minute infusion period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Systolic Blood Pressure

Secondary study objectives

Circulating Renin-Angiotensin System Components

Hemodynamic Measures

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Autonomic Blockade Study DayExperimental Treatment3 Interventions

Autonomic blockade will be induced by continuous intravenous infusion of trimethaphan starting at 0.5-1.0 mg/min and increasing by 1.0 mg/min every 2 to 6 minutes up to an infusion rate of 5 mg/min. Blood pressure will be restored to pre-trimethaphan levels with intravenous phenylephrine infusion at individually titrated doses, starting with 0.1 ug/kg/min. Angiotensin (1-7) will then be infused in five ascending doses ranging from 0.5 to 20 ng/kg/min. Each dose will be maintained for 10 minutes with hemodynamic measurements and blood samples collected at the end of each dosing period.

Group II: Intact Study DayActive Control1 Intervention

Subjects will receive saline infusion for 60 minutes followed by five ascending doses of Angiotensin (1-7) ranging from 0.5 to 20 ng/kg/min. Each dose will be maintained for 10 minutes with hemodynamic measurements and blood samples collected at the end of each dosing period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trimethaphan

2010

Completed Phase 1

~300

Phenylephrine

2014

Completed Phase 4

~2040

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, and diuretics. ACE inhibitors and ARBs work by inhibiting the renin-angiotensin-aldosterone system (RAAS), which reduces vasoconstriction and decreases blood volume, leading to lower blood pressure. Calcium channel blockers prevent calcium from entering the heart and blood vessel walls, causing vasodilation and reduced blood pressure. Diuretics help the kidneys remove excess sodium and water from the body, decreasing blood volume and pressure. These treatments are crucial for managing high blood pressure as they help prevent complications such as heart attack, stroke, and kidney damage. The study of Angiotensin (1-7) infusion, a vasodilatory peptide, is significant as it may offer additional or alternative mechanisms to further improve blood pressure control by directly promoting vasodilation.

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Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor

709 Previous Clinical Trials

6,143,684 Total Patients Enrolled

Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University

Vanderbilt University

28 Previous Clinical Trials

1,430 Total Patients Enrolled

Media Library

Angiotensin (1-7) (Vasodilatory Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT02245230 — Phase 1

High Blood Pressure Research Study Groups: Intact Study Day, Autonomic Blockade Study Day

High Blood Pressure Clinical Trial 2023: Angiotensin (1-7) Highlights & Side Effects. Trial Name: NCT02245230 — Phase 1

Angiotensin (1-7) (Vasodilatory Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02245230 — Phase 1

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