Improving metabolic health in Black individuals using natriuretic peptide augmentation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of natriuretic peptide augmentation on cardiometabolic health specifically in Black individuals, who are at a higher risk for diabetes due to lower levels of these hormones. The study will utilize sacubitril/valsartan, an FDA-approved medication that inhibits neprilysin, to increase natriuretic peptide levels and potentially improve insulin sensitivity and energy expenditure. Participants will undergo various assessments, including intravenous glucose tolerance tests and standardized meals, to evaluate the impact of the intervention on their metabolic health. The goal is to better understand the relationship between natriuretic peptides and the risk of cardiometabolic diseases in this population.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Pankaj Arora, MD, FAHA — University of Alabama at Birmingham
• Study coordinator: Nehal Vekariya, MS
• Email: nvekariya@uabmc.edu
• Phone: 205-934-7173

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.