NCT04055428 · University of Alabama at Birmingham
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
What this study 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.
View original scientific description
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.
Interventions
DRUG
Sacubitril, Valsartan 97-103 mg Oral Tablet
The subject will be randomized, in a double-blind manner to sacubitril/valsartan 97/103 mg twice daily for a period of 12 weeks.
DRUG
Valsartan 160 mg
The subject will be randomized, in a double-blind manner to valsartan 160 mg twice daily for a period of 12 weeks.
OTHER
Intravenous Glucose Tolerance Test
An assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.
DIETARY_SUPPLEMENT
Standardized Meals
Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.
OTHER
Exercise capacity VO2 maximum determination
Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.
Primary outcome measures
Change in insulin sensitivity after natriuretic peptide augmentation
Time frame: 12 weeks
An assessment of the insulin sensitivity will be done at baseline and after 12 weeks of pharmacological intervention.
Change in energy expenditure after natriuretic peptide augmentation
Time frame: 12 weeks
An assessment of the resting energy expenditure will be done at baseline and after 12 weeks of pharmacological intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations