RecruitingPhase 2NCT04055428

NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals

The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)


Sponsor

University of Alabama at Birmingham

Enrollment

200 participants

Start Date

Aug 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity \& energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

Black Americans have lower levels of a heart-protective hormone called natriuretic peptide, which may partly explain why they have higher rates of high blood pressure and heart disease. The NAUTICAL study tests a drug called sacubitril/valsartan that boosts natriuretic peptide levels, to see whether it improves heart and metabolic health in Black individuals with mildly elevated blood pressure. This trial enrolls self-identified Black or African-American adults with blood pressure in a specific range (120–160/80–100 mmHg). Participants must be able to exercise on a treadmill. People with a history of cardiovascular disease, diabetes, smoking in the past year, or kidney disease are excluded. You may be eligible if: - You are 18 years or older - You self-identify as African-American or Black - Your blood pressure is between 120–160 systolic and 80–100 diastolic mmHg - You are able to exercise on a treadmill You may NOT be eligible if: - You have a history of cardiovascular disease (stroke, heart attack, heart failure, angina, arrhythmia) - You have diabetes or a fasting blood sugar of 126 mg/dL or higher - You have a history of angioedema - You have smoked in the past 12 months - Your estimated kidney filtration rate (GFR) is below 60 mL/min - You have significant liver enzyme elevations (above 3x normal) - You drink more than 2 alcoholic drinks daily - You are pregnant, breastfeeding, or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacubitril, Valsartan 97-103 mg Oral Tablet

The subject will be randomized, in a double-blind manner to sacubitril/valsartan 97/103 mg twice daily for a period of 12 weeks.

DRUGValsartan 160 mg

The subject will be randomized, in a double-blind manner to valsartan 160 mg twice daily for a period of 12 weeks.

OTHERIntravenous Glucose Tolerance Test

An assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.

DIETARY_SUPPLEMENTStandardized Meals

Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.

OTHERExercise capacity VO2 maximum determination

Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT04055428


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