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

Description

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.

Conditions

HIV/AIDS, Heart Failure With Preserved Ejection Fraction

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Study Overview

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Study Details

Study overview

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.

Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study

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

Condition
HIV/AIDS
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Antiretroviral therapy use for \>12 months
  • 2. HIV Viral Load \<200 copies/mL
  • 3. Left Ventricular Ejection Fraction\>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 \<18%
  • * Left Ventricular Mass Index \> 95g/m2 (female), 115 g/m2 (male)
  • 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 RAAS pathway (ACEi, ARB, MR blockade, direct renin inhibitor), potassium (K) supplementation or diuretic
  • 4. Angioedema to ACEi or ARB
  • 5. SBP\<100 mmHg
  • 6. Medication suspected to have contraindication with active study drug
  • 7. Steroid use within last 3 months
  • 8. Uncontrolled diabetes requiring insulin and/or HbA1c \> 7.5%
  • 9. Creatinine (Cr)\>1.5 mg/dL and estimated GFR\<60 mL/min/1.73m2
  • 10. K\>5.5 mEq/L
  • 11. Hemoglobin \<10.0 g/dL
  • 12. Known liver disease or ALT\>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

Ages Eligible for Study

40 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2024-12-31