Evaluating a medication for heart health in people with HIV
Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study
This study is testing if a heart medication can help people with HIV who have early signs of heart problems feel better and improve their heart health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04153136 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of sacubitril/valsartan, a medication typically used for heart failure, on individuals with HIV who show early signs of heart dysfunction but have no known history of heart disease. Participants will undergo cardiac imaging and blood tests to assess heart structure and function before being randomly assigned to receive either the medication or a placebo for six months. The goal is to determine if this treatment can improve cardiovascular health by addressing inflammation and heart muscle changes associated with HIV.
Who should consider this trial
Good fit: Ideal candidates are individuals with HIV who have been on antiretroviral therapy for over 12 months and show early signs of heart dysfunction.
Not a fit: Patients with a known history of heart disease or those currently on medications affecting the RAAS pathway may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart health and reduced risk of heart failure for patients living with HIV.
How similar studies have performed: While the use of sacubitril/valsartan in HIV-related heart failure is novel, similar studies in heart failure populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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) Exclusion Criteria: 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Suman Srinivasa, MD, MS
- Email: ssrinivasa@mgh.harvard.edu
- Phone: 6177269109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.