NCT04153136CompletedPhase 2
The ENCHANTMENT HIV Study
Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 30 Oct 2019
- Start date
- 11 Sept 2020
- Primary completion date
- 9 Jul 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Heart failure, HIV
- NCT number
- NCT04153136
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 39
- From 11 Sept 2020 to the primary completion date, 9 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication suspected to have contraindication with active study drug
- Steroid use within last 3 months
- Estrogen, progestin derivative, or other sex steroid use within 3 months. Stable physiologic testosterone replacement (\> 3 months) is acceptable
Other illness
- Known history of congestive heart failure or valvular disease
- Recent cardiac event or stroke within 3 months
- Current bacterial or other infection
Lab values
- 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
- Uncontrolled diabetes requiring insulin and/or hemoglobin A1c (HbA1c) \> 7.5%
- Creatinine (Cr)\>1.5 mg/dL and estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2
- Hemoglobin \<10.0 g/dL
- Known liver disease or alanine transaminase (ALT)\>3x upper limit normal
Other
- Angioedema to ACEi or ARB
- Systolic blood pressure\<100 mmHg
- K\>5.5 mEq/L
- Pregnant, actively seeking pregnancy or breastfeeding
- Active substance abuse
- Known reaction to gadolinium
Who the study is looking for
- 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)
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.