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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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 criteria

Qualifiers

Adults: Age more than or equal to 18 years of age

Self-identified race/ethnicity as African-American or Black

Blood pressure: 120-160/80-100 mmHg

Disqualifiers

Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)

Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)

BP more than 160/100 mmHg

BMI >45 kg/m2

Trial design

Treatments tested in this trial

  • Sacubitril, Valsartan 97-103 mg Oral Tablet
  • Valsartan 160 mg
  • Intravenous Glucose Tolerance Test
  • Standardized Meals
  • Exercise capacity VO2 maximum determination

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator