Cardiovascular Diseases Clinical Trial
Official title:
The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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Jordan J, Stinkens R, Jax T, Engeli S, Blaak EE, May M, Havekes B, Schindler C, Albrecht D, Pal P, Heise T, Goossens GH, Langenickel TH. Improved Insulin Sensitivity With Angiotensin Receptor Neprilysin Inhibition in Individuals With Obesity and Hypertens — View Citation
Patel N, Cushman M, Gutierrez OM, Howard G, Safford MM, Muntner P, Durant RW, Prabhu SD, Arora G, Levitan EB, Arora P. Racial differences in the association of NT-proBNP with risk of incident heart failure in REGARDS. JCI Insight. 2019 Jun 4;5(13):e129979 — View Citation
Seferovic JP, Claggett B, Seidelmann SB, Seely EW, Packer M, Zile MR, Rouleau JL, Swedberg K, Lefkowitz M, Shi VC, Desai AS, McMurray JJV, Solomon SD. Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Metabolomic Profile | The change in the metabolomic profile examined using standardized platforms after 12 weeks of intervention. | 12 weeks | |
Primary | Change in insulin sensitivity after natriuretic peptide augmentation | An assessment of the insulin sensitivity will be done at baseline and after 12 weeks of pharmacological intervention. | 12 weeks | |
Primary | Change in energy expenditure after natriuretic peptide augmentation | An assessment of the resting energy expenditure will be done at baseline and after 12 weeks of pharmacological intervention. | 12 weeks | |
Secondary | Change in exercise energy expenditure after 12 weeks of pharmacological intervention. | During standardized protocol after 12 weeks of intervention, the energy expenditure will be calculated using metabolic cart. | 12 weeks | |
Secondary | Change in post-meal increase in GLP-1 levels | Change in GLP-1 levels after a standardized meal after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in peak oxygen consumption after 12 weeks of pharmacological intervention. | Change in the peak oxygen consumption (VO2 max) after 12 weeks of intervention. | 12 weeks | |
Secondary | Change in fasting GLP-1 levels | Change in fasting GLP-1 levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in natriuretic peptide levels | Change in natriuretic peptide levels (ANP, MRproANP, BNP, NTproBNP) after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in measures of insulin sensitivity | Change in measures of insulin sensitivity (AIRg, Sg, Kg, Disposition Index) after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in HBA1c levels | Change in HBA1c levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in fasting blood glucose levels | Change in fasting blood glucose levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in HOMA-IR | Change in HOMA-IR after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in fasting insulin levels | Change in fasting insulin levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in measures of body mass index | Change in the measures of body mass index after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in measures of hip circumference | Change in the measures of hip circumference after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in measures of waist circumference | Change in the measures of waist circumference after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in measures of adipose tissue mass | Change in the measures of adipose tissue mass after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in total cholesterol levels | Change in the total cholesterol levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in LDL-C levels | Change in LDL-C levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in HDL-C levels | Change in HDL-C levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Change in triglyceride levels | Change in triglyceride levels after 12 weeks of pharmacological intervention | 12 weeks | |
Secondary | Correlation of change in MR-pro atrial natriuretic peptide levels with change in insulin sensitivity after 12 weeks of pharmacological intervention. | The exposure-response relationship of change in MR-pro atrial natriuretic peptide levels with change in insulin sensitivity after 12 weeks of intervention will be examined. | 12 weeks | |
Secondary | Correlation of change in MR-pro atrial natriuretic peptide levels with change in energy expenditure after 12 weeks of pharmacological intervention. | The exposure-response relationship of change in MR-pro atrial natriuretic peptide levels with change in resting and exercise energy expenditure after 12 weeks of intervention will be examined. | 12 weeks | |
Secondary | Correlation of change in B-type natriuretic peptide levels with change in insulin sensitivity after 12 weeks of pharmacological intervention. | The exposure-response relationship of change in B-type natriuretic peptide levels with change in insulin sensitivity after 12 weeks of intervention will be examined. | 12 weeks | |
Secondary | Correlation of change in B-type natriuretic peptide levels with change in resting energy expenditure after 12 weeks of pharmacological intervention. | The exposure-response relationship of change in B-type natriuretic peptide levels with change in resting energy expenditure after 12 weeks of intervention will be examined. | 12 weeks | |
Secondary | Correlation of change in NT-pro B-type natriuretic peptide levels with change in insulin sensitivity after 12 weeks of pharmacological intervention. | The exposure-response relationship of change in NT-pro B-type natriuretic peptide levels with change in insulin sensitivity after 12 weeks of intervention will be examined. | 12 weeks | |
Secondary | Correlation of change in NT-pro B-type natriuretic peptide levels with change in energy expenditure after 12 weeks of pharmacological intervention. | The exposure-response relationship of change in NT-pro B-type natriuretic peptide levels with change in resting and exercise energy expenditure after 12 weeks of intervention will be examined. | 12 weeks | |
Secondary | Impact of Natriuretic Peptide Genotype on Study Endpoints | All study outcomes will be analyzed by natriuretic peptide genotypes | 12 weeks |
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