Actively Recruiting
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
Led by University of Alabama at Birmingham · Updated on 2025-07-03
200
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Self-identified as African-American or Black
- Blood pressure between 120-160/80-100 mmHg
You will not qualify if you...
- Women who are pregnant, breastfeeding, or able to become pregnant without acceptable birth control
- History of cardiovascular diseases including stroke, heart attack, heart failure, transient ischemic attack, angina, or arrhythmia
- Blood pressure higher than 160/100 mmHg
- Body mass index over 45 kg/m2
- History of diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
- History of angioedema
- Current or past history of smoking within the last 12 months
- Estimated glomerular filtration rate below 60 ml/min/1.73 m2 or albumin-creatinine ratio ≥30 mg/g
- Liver enzyme levels (AST and ALT) more than three times the upper limit of normal
- Significant psychiatric illness or seizure disorder
- Consuming more than two alcoholic drinks daily
- Anemia (men: hematocrit <38%, hemoglobin <13 g/dL; women: hematocrit <36%, hemoglobin <12 g/dL)
- Inability to exercise on a treadmill
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
N
Nehal Vekariya, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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