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