VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Mar 13, 2024

Keywords

ClinConnect Summary

The VITAL-IMPACT study is looking into a new treatment called vericiguat to see if it can help improve heart and metabolic health in Black individuals who are obese and have insulin resistance. Insulin resistance is a condition where the body doesn't use insulin properly, which can lead to higher risks of heart disease and other health problems. This trial will involve 200 participants who will take either vericiguat or a placebo (a non-active pill) for 12 weeks. The researchers hope that by boosting a specific signaling pathway in the body, they can enhance how well the body uses insulin and burns energy.

To be eligible for the study, participants must be at least 18 years old, self-identify as African-American or Black, and have a body mass index (BMI) of 30 or higher. They should also have signs of insulin resistance. However, people with certain health conditions, such as severe heart problems or diabetes, cannot participate. Those who join the study can expect to undergo various tests to measure their insulin sensitivity and energy use during exercise and rest. This research aims to provide valuable insights into how improving this signaling pathway can lead to better health outcomes for Black individuals facing obesity and metabolic challenges.

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
• • BMI ≥ 30 kg/m2
• • HOMA-IR ≥ 2.5
• • Blood pressure: 120-160/80-100 mmHg (untreated or 1 week of washout in those treated with up to two classes of antihypertensives)
• • Willing to adhere to study protocol
• 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, seizure or cardiac arrhythmia)
• • BP more than 160/100 mmHg or those treated with three or more classes of antihypertensives
• • BMI \>45 kg/m2
• • History of diabetes or fasting plasma glucose \>=126 mg/dL or HbA1C\>=6.5% or prior treatment with antidiabetics
• • 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 (assessed using validated MINI questionnaire)
• • Anemia (men, Hb\<13 g/dL; women, Hb \<12 g/dL)
• • Inability to exercise on a treadmill