Status:
RECRUITING
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Diabetes Mellitus
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. N...
Detailed Description
Black individuals are more likely to have a reduced insulin sensitivity which results in a greater risk for diabetes. However, the reasons for their decreased insulin sensitivity are not clearly under...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04055428
Start Date
August 15 2020
End Date
May 31 2027
Last Update
July 3 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294