RECRUITING

NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)

Quick Facts

Study Start:2020-08-15
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04055428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults: Age more than or equal to 18 years of age
  2. * Self-identified race/ethnicity as African-American or Black
  3. * Blood pressure: 120-160/80-100 mmHg
  1. * 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)
  2. * Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)
  3. * BP more than 160/100 mmHg
  4. * BMI \>45 kg/m2
  5. * History of diabetes or fasting plasma glucose \>=126 mg/dL or HbA1C\>=6.5%
  6. * History of angioedema
  7. * Current or past (\<12 months) history of smoking
  8. * Estimated GFR \< 60 ml/min/1.73 m2; albumin-creatinine ratio ≥30 mg/g
  9. * Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
  10. * Significant psychiatric illness or seizure disorder
  11. * More than 2 Alcoholic drinks daily
  12. * Anemia (men, Hct \< 38%, Hb\<13 g/dL; women, Hct \<36%, Hb \<12 g/dL)
  13. * Inability to exercise on a treadmill

Contacts and Locations

Study Contact

Nehal Vekariya, MS
CONTACT
205-934-7173
nvekariya@uabmc.edu

Principal Investigator

Pankaj Arora, MD, FAHA
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Pankaj Arora, MD, FAHA, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-15
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2020-08-15
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Natriuretic Peptides
  • Diabetes
  • Insulin Sensitivity
  • Energy Expenditure

Additional Relevant MeSH Terms

  • Diabetes Mellitus
  • Cardiovascular Diseases
  • Insulin Sensitivity/Resistance
  • Metabolic Disease
  • Natriuretic Peptides
  • Metabolism
  • Energy Expenditure