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

University of Alabama at Birmingham · with National Heart, Lung, and Blood Institute (NHLBI) · NCT04055428

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
200
US sites recruiting
1
Study start
August 15, 2020
Record last updated
July 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

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

Conditions: Diabetes Mellitus; Cardiovascular Diseases; Insulin Sensitivity/Resistance; Metabolic Disease; Natriuretic Peptides; Metabolism; Energy Expenditure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • History of diabetes or fasting plasma glucose >=126 mg/dL or HbA1C>=6.5%
  • History of angioedema
  • Current or past (\<12 months) history of smoking
  • Estimated GFR \< 60 ml/min/1.73 m2; albumin-creatinine ratio ≥30 mg/g
  • Hepatic Transaminase (AST and ALT) levels >3x the upper limit of normal
  • Significant psychiatric illness or seizure disorder
  • More than 2 Alcoholic drinks daily
  • Anemia (men, Hct \< 38%, Hb\<13 g/dL; women, Hct \<36%, Hb \<12 g/dL)
  • Inability to exercise on a treadmill

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35294

    Site contact: Nehal Vekariya, MS · 205-934-7173 · nvekariya@uabmc.edu

Study contacts (from the official record)

  • Nehal Vekariya, MS · 205-934-7173 · nvekariya@uabmc.edu
All diabetes studies in Alabama →
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