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Completed NCT04153136

The ENCHANTMENT HIV Study

Conditions: HIV/AIDS, Heart Failure With Preserved Ejection Fraction

Sex: All
Ages: 40 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 39
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

Summary

Persons with HIV, even those well-treated, are at increased risk for heart disease when compared to the general population. Two hormones called aldosterone and brain natriuretic peptide (BNP), which have been shown to be abnormal in HIV, may be associated with inflammation as well as early changes in structure and function of the heart. This study is being conducted to evaluate whether therapies to block aldosterone and increase BNP levels may reduce the burden and progression of heart failure to improve cardiovascular health.

Eligibility Criteria

Inclusion Criteria: 1. Antiretroviral therapy use for \>12 months 2. HIV Viral Load \50% 4. Demonstration of one or more criteria for myocardial dysfunction on cardiac transthoracic echocardiogram, relevant to the progression of heart failure with preserved ejection fraction: * Left Atrial Volume Index \> 28 mL/m2 * Global Longitudinal Strain \ 95g/m2 (female), 115 g/m2 (male) Exclusion Criteria: 1. Known history of congestive heart failure or valvular disease 2. Recent cardiac event or stroke within 3 months 3. Current medication use acting along the renin-angiotensin-aldosterone-system (RAAS) pathway \[angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), mineralocorticoid receptor blockade, direct renin inhibitor), potassium (K) supplementation or diuretic 4. Angioedema to ACEi or ARB 5. Systolic blood pressure\ 7.5% 9. Creatinine (Cr)\>1.5 mg/dL and estimated glomerular filtration rate (eGFR) \5.5 mEq/L 11. Hemoglobin \3x upper limit normal 13. Pregnant, actively seeking pregnancy or breastfeeding 14. Estrogen, progestin derivative, or other sex steroid use within 3 months. Stable physiologic testosterone replacement (\> 3 months) is acceptable 15. Current bacterial or other infection 16. Active substance abuse 17. Known reaction to gadolinium

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04153136). StuddyBuddy aggregates publicly available trial information.