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

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Alabama at Birmingham
NCT04055428 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
University of Alabama at Birmingham
Birmingham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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