Racial differences in the association of NT-proBNP with risk of incident heart failure in REGARDS.
Nirav Patel, Mary Cushman, Orlando M Gutiérrez...
https://pubmed.ncbi.nlm.nih.gov/31162140/Actively Recruiting
Led by University of Alabama at Birmingham · Updated on 2026-07-28
200
Participants Needed
1
Research Sites
21 weeks
Total Duration
Black individuals often have reduced insulin sensitivity, increasing their risk for cardiometabolic diseases like diabetes. This study evaluates whether increasing levels of natriuretic peptides NPs, hormones produced by the heart that influence metabolism, can improve metabolic health in Black individuals. The study focuses on the role of low NP levels in contributing to higher diabetes risk and tests the effects of NP augmentation through medication. Participants will be randomly assigned to receive either sacubitrilvalsartan, which increases NP levels by inhibiting the enzyme neprilysin, or valsartan alone. Both medications are taken twice daily for 12 weeks. The study compares changes in insulin sensitivity, energy expenditure at rest and during exercise, and post-meal hormone responses between the two groups. Assessments include intravenous glucose tolerance tests, standardized meal tests, and treadmill exercise protocols. During the trial, participants will be evaluated at the start and after 12 weeks of treatment to measure insulin sensitivity, energy use, and hormone levels related to metabolism. Various blood tests and exercise capacity measurements will be performed to monitor changes. The research also tracks safety and metabolic health markers to understand the impact of NP augmentation on cardiometabolic risk in Black adults.
CONDITIONS
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
N
Nehal Vekariya, MS
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University of Alabama at Birmingham
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Sacubitril/Valsartan 97/103 mg | Valsartan 160 mg |
|---|---|---|
| What it is | A single-tablet combination of sacubitril (a neprilysin inhibitor) and valsartan (an angiotensin receptor blocker) taken twice daily to increase natriuretic peptide activity in the body. | Valsartan is an angiotensin receptor blocker (ARB) taken twice daily as an established treatment for blood pressure control. |
| Role in the study | Randomized investigational intervention; evaluates effects of natriuretic peptide augmentation on insulin sensitivity and energy use. | Active comparator; tests whether observed effects are due to neprilysin inhibition or standard ARB therapy alone. |
| Primary use in clinical practice | Outside the trial, sacubitril/valsartan is primarily approved for heart failure with reduced ejection fraction, but is being studied here for effects on metabolic health and insulin sensitivity in Black adults without heart failure. | Valsartan is an established ARB, widely used for treating high blood pressure, including among Black adults. |
| How it is taken | Taken orally as a tablet twice daily for 12 weeks. | Oral tablet taken twice daily for 12 weeks. |
| Evidence status | Evidence from prior studies shows sacubitril/valsartan may improve insulin sensitivity in people with obesity and high blood pressure. Effects on those without diabetes, and specifically in Black adults, remain under active investigation. | Valsartan effectively lowers blood pressure, but its effects on insulin sensitivity are less pronounced compared to sacubitril/valsartan in prior studies. |
| Important limitations | Benefits for insulin sensitivity and metabolic health in Black individuals without diabetes are not yet established and longer-term outcomes are unknown. | Does not address natriuretic peptide augmentation; evidence for metabolic improvements in populations without diabetes or metabolic syndrome is limited. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take either sacubitril/valsartan or valsartan twice daily for 12 weeks while undergoing metabolic assessments.
Visits at baseline and after 12 weeks for testing
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/28330649/University of Alabama at Birmingham
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor