The ENCHANTMENT HIV Study
Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study
1 other identifier
interventional
39
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedStudy Start
First participant enrolled
September 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2025
CompletedMarch 11, 2026
March 1, 2026
4.8 years
October 30, 2019
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Myocardial Inflammation/Fibrosis
Myocardial Inflammation/Fibrosis measured by extracellular volume fraction via cardiac magnetic resonance imaging
6 months
Myocardial Dysfunction
Left Atrial Volume Index or Global Longitudinal Strain measured by cardiac transthoracic echocardiography
6 months
Secondary Outcomes (3)
Other Indices of Myocardial Dysfunction
6 months
Markers of Myocardial Inflammation and Fibrosis
6 months
Cardiac Natriuretic Peptides
6 months
Study Arms (2)
Sacubitril/Valsartan
EXPERIMENTALSacubitril/Valsartan 49-51mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months
Placebo
PLACEBO COMPARATORPlacebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months
Interventions
By mouth twice daily
Eligibility Criteria
You may qualify if:
- 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:
- Left Atrial Volume Index \> 28 mL/m2
- Global Longitudinal Strain \<18%
- Left Ventricular Mass Index \> 95g/m2 (female), 115 g/m2 (male)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (3)
Srinivasa S, Fitch KV, Wong K, Torriani M, Mayhew C, Stanley T, Lo J, Adler GK, Grinspoon SK. RAAS Activation Is Associated With Visceral Adiposity and Insulin Resistance Among HIV-infected Patients. J Clin Endocrinol Metab. 2015 Aug;100(8):2873-82. doi: 10.1210/jc.2015-1461. Epub 2015 Jun 18.
PMID: 26086328BACKGROUNDMurphy CA, Fitch KV, Feldpausch M, Maehler P, Wong K, Torriani M, Adler GK, Grinspoon SK, Srinivasa S. Excessive Adiposity and Metabolic Dysfunction Relate to Reduced Natriuretic Peptide During RAAS Activation in HIV. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1558-1565. doi: 10.1210/jc.2017-02198.
PMID: 29408981BACKGROUNDSrinivasa S, Fitch KV, Wong K, O'Malley TK, Maehler P, Branch KL, Looby SE, Burdo TH, Martinez-Salazar EL, Torriani M, Lyons SH, Weiss J, Feldpausch M, Stanley TL, Adler GK, Grinspoon SK. Randomized, Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Metabolic and Inflammatory Indices in HIV. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2376-2384. doi: 10.1210/jc.2018-00330.
PMID: 29659888BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 6, 2019
Study Start
September 11, 2020
Primary Completion
July 9, 2025
Study Completion
July 9, 2025
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share