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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
Study Summary
This trial will study the effects of a vasodilatory peptide on blood pressure in people with hypertension. The hypothesis is that the peptide has little effect when the body's baroreceptors are working, but its effects are seen when the baroreceptors are not functioning.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Systolic Blood Pressure
Secondary outcome measures
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
~2050
Find a Location
Who is running the clinical trial?
Vanderbilt UniversityLead Sponsor
703 Previous Clinical Trials
6,143,323 Total Patients Enrolled
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University
Vanderbilt University
28 Previous Clinical Trials
1,430 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of immune system or blood disorders.You have had a serious brain blood vessel problem like a stroke or brain bleed in the past.People of any race who are between 18 and 60 years old, both men and women.Your blood pressure is consistently higher than 130/85 mmHg.You have been taking strong steroid medication for more than a week each month.You are currently taking phosphodiesterase 5 inhibitors.You are currently taking blood thinners.You are a current smoker or used to smoke a lot.You have a history of drinking too much alcohol or using drugs.You have been diagnosed with type I or type II diabetes, or you have high fasting glucose levels.Your liver function tests show that your liver is not working as it should.You have had a heart attack, chest pain, irregular heartbeats, heart failure, blood clots, or certain heart valve problems in the past 6 months.Your hemoglobin levels are lower than 13.5 g/dl if you are male, or lower than 12.5 g/dl if you are female.Your kidneys are not working well (your serum creatinine level is higher than 1.5 mg/dl).
Research Study Groups:
This trial has the following groups:- Group 1: Intact Study Day
- Group 2: Autonomic Blockade Study Day
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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