CompletedPhase 2

The ENCHANTMENT HIV Study

United States39 participantsStarted 2020-09-11

Plain-language 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.

Who can participate

Age range40 Years – 70 Years

SexALL

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Inclusion criteria

✓. Antiretroviral therapy use for \>12 months
✓. HIV Viral Load \<200 copies/mL
✓. Left Ventricular Ejection Fraction\>50%
✓. Demonstration of one or more criteria for myocardial dysfunction on cardiac transthoracic echocardiogram, relevant to the progression of heart failure with preserved ejection fraction:

Exclusion criteria

✕. Known history of congestive heart failure or valvular disease
✕. Recent cardiac event or stroke within 3 months
✕. Current medication use acting along the RAAS pathway (ACEi, ARB, MR blockade, direct renin inhibitor), potassium (K) supplementation or diuretic
✕. Angioedema to ACEi or ARB
✕. SBP\<100 mmHg
✕. Medication suspected to have contraindication with active study drug
✕. Steroid use within last 3 months
✕. Uncontrolled diabetes requiring insulin and/or HbA1c \> 7.5%

What they're measuring

Myocardial Inflammation/Fibrosis

Timeframe: 6 months

Myocardial Dysfunction

Timeframe: 6 months

Trial details

NCT IDNCT04153136

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-09

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