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

• Status: Recruiting
• Trial end date: 2026-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Insulin; LCZ 696; Valsartan

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 (either untreated or after 4 weeks of washout in those treated with up to two classes of antihypertensives)

• Baseline insulin resistance: HOMA-IR ≥2.5

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