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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Aug 10, 2019

Keywords

ClinConnect Summary

The NAUTICAL trial is studying how increasing levels of certain hormones called natriuretic peptides (NPs) can improve metabolic health in Black individuals who are at a higher risk for diabetes and heart-related issues. These hormones, which are produced by the heart, help regulate how our bodies use energy and manage insulin, a hormone that controls blood sugar levels. The study will test whether a medication called sacubitril/valsartan can boost NP levels and lead to better insulin sensitivity and energy use in these individuals.

To participate, you need to be at least 18 years old, identify as African-American or Black, and have a specific range of blood pressure. However, there are some health conditions that may exclude you, such as a history of heart disease, diabetes, or certain kidney and liver issues. If you join the trial, you'll be monitored closely to see how the treatment affects your metabolic health. This study is important because it aims to better understand the connection between natriuretic peptides and the increased risk of diabetes in Black individuals, potentially leading to new ways to improve health in this community.

Gender

ALL

Eligibility criteria

• 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