Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    50
  • sponsor
    Massachusetts General Hospital
Updated on 4 October 2022
heart failure
antiretroviral agents
antiretroviral therapy
hiv viral load
aldosterone
heart disease
b-type natriuretic peptide
natriuretic peptide
valsartan

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.

Description

This is a 6-month study enrolling persons with HIV with no known history of heart disease. Participants will be screened for early signs of heart failure using cardiac ultrasound (cardiac transthoracic echocardiography or cardiac TTE). Those participants who have early changes in the structure and function of the heart and may be at future risk for heart failure will be enrolled into the study. Additional imaging of the heart will occur using cardiac magnetic resonance imaging (cardiac MRI). Following baseline studies, participants will either receive a medication called sacubitril/valsartan or placebo for 6 months. Sacubitril/valsartan in an FDA approved medication currently being used for heart failure with reduced ejection fraction in the general population, and we are evaluating whether this medication could be useful to reduce HIV-related heart failure with preserved ejection fraction. Sacubitril/valsartan is an oral medication taken twice daily that may block aldosterone hormone and increase natriuretic peptide hormone. Overall, this study aims to investigate the effect of sacubitril/valsartan on measures of heart disease related to inflammation, structure and function of the heart muscle in HIV using cardiac TTE and cardiac MRI imaging as well as blood markers of heart failure and inflammation.

Details
Condition HIV/AIDS, Heart Failure With Preserved Ejection Fraction
Treatment Placebo Oral Tablet, Sacubitril-Valsartan 49-51Mg Oral Tablet
Clinical Study IdentifierNCT04153136
SponsorMassachusetts General Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Antiretroviral therapy use for >12 months
HIV Viral Load <200 copies/mL
Increased waist circumference based on NCEP criteria (male>102cm2 and female>88cm2) or increased waist to hip ratio based on WHO criteria (male>0.95 and female>0.80)
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
Left Atrial Volume Index > 28 mL/m2
Global Longitudinal Strain <18%
Left Ventricular Mass Index > 95g/m2 (female), 115 g/m2 (male)

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%
Creatinine (Cr)>1.5 mg/dL and estimated GFR<60 mL/min/1.73m2
K>5.5 mEq/L
Hemoglobin <10.0 g/dL
Known liver disease or ALT>3x upper limit normal
Pregnant, actively seeking pregnancy or breastfeeding
Estrogen, progestin derivative, or other sex steroid use within 3 months. Stable physiologic testosterone replacement (> 3 months) is acceptable
Current bacterial or other infection
Active substance abuse
Known reaction to gadolinium
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