Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2029-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Obesity is a global health concern that is associated with high blood pressure and an increased risk for developing cardiovascular disease. The purpose of this study is to find out if the investigational drug angiotensin-(1-7) can improve cardiovascular health in people with obesity and high blood pressure.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Angiotensin 1-7 in Obesity Hypertension

NCT03604289

Obesity Hypertension

TERMINATED EARLY_PHASE1

Angiotensin-(1-7) Cardiovascular Effects in Aging

NCT05301192

Aging

RECRUITING EARLY_PHASE1

Angiotensin-(1-7) and Energy Expenditure in Human Obesity

NCT03777215

Obesity

ACTIVE_NOT_RECRUITING EARLY_PHASE1

Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension

NCT02245230

Hypertension Hypertension, Essential

TERMINATED PHASE1

Effect of Blood Pressure on Myocardial Work in Patients With Hypertension

NCT05062811

Hypertension; Heart Disease, Hypertensive

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A randomized, double blind, placebo controlled, crossover study will be conducted to determine if acute intravenous angiotensin-(1-7) infusion reduces cardiovascular sympathetic tone and blood pressure and improves the function of blood vessels in participants with obesity hypertension. This is an outpatient study that requires a screening visit, and if eligible, two study visits separated by at least one week in the Clinical Research Center within the Penn State Milton S. Hershey Medical Center. The study visits will include intravenous infusion of angiotensin-(1-7) or saline for approximately two hours, starting with increasing doses and holding at a steady-state dose. Endothelial function will be measured and blood samples collected at baseline and at the end of infusion. Blood pressure, heart rate, and muscle sympathetic nerve activity (via microneurography) will be measured continuously throughout the study. Each study visit will last approximately 4 hours.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Angiotensin-(1-7)

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 Type EXPERIMENTAL

Angiotensin-(1-7)

Intervention Type DRUG

This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.

Saline

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline will be used as the placebo comparator.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Angiotensin-(1-7)

This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.

Intervention Type DRUG

Saline

Saline will be used as the placebo comparator.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Angiotensin I/II (1-7) Acetate Normal saline 0.9% sodium chloride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women of all races
* Age 18 to 65 years
* Body mass index (BMI) between 30-45 kg/m2
* Pre-hypertension (defined as two or more seated blood pressure readings \>120/80 mmHg) or hypertension (defined as two or more seated blood pressure readings \>130/80 mmHg or use of antihypertensive medications)
* Capable of giving informed consent
* Fluent in written and spoken English
* Satisfactory history and physical exam

Exclusion Criteria

* Age ≤ 17 or ≥ 66 years
* Taking more than two antihypertensive medications
* Secondary causes of hypertension (e.g., pheochromocytoma, primary aldosteronism, aortic coarctation, adrenal disease)
* Pregnant or nursing women
* Women taking hormone replacement therapy within 6 months
* Decisional impairment
* Prisoners
* Alcohol or drug abuse
* Current smokers
* Highly trained athletes
* Subjects with \>5% weight change in the past 3 months
* BMI \> 45 kg/m2
* Evidence of type I or type II diabetes (fasting glucose \> 126 mg/dL or use of anti-diabetic medications)
* 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 \[aspartate aminotransferase (AST) or alanine transaminase (ALT) levels \>2 times upper limit of normal range\]
* Impaired renal function (serum creatinine \>2.0 mg/dl)
* Anemia
* Treatment with drugs increasing sympathetic activity \[e.g., serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors, stimulants\]
* Treatment with phosphodiesterase-5 inhibitors
* Treatment with anticoagulants (e.g. warfarin)
* Treatment with chronic systemic glucocorticoid therapy (\>7 consecutive days in 1 month)
* Treatment with any investigational drug in the 1-month preceding the study
* Inability to give, or withdraw, informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No