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Could a common heart drug protect HIV patients from heart failure?

NCT ID NCT04153136

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a drug called sacubitril-valsartan (Entresto) can improve early signs of heart failure in people with HIV. The 39 participants had well-controlled HIV but showed subtle heart changes on scans. The goal was to see if the drug could reduce inflammation and improve heart function, potentially preventing full-blown heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacubitril-Valsartan (Entresto)
What this could lead to
If successful, this could point toward a way to prevent or slow heart failure in people with HIV.
What could go wrong
This is a small, early-phase study with only 39 participants. It may not show clear benefits, and the drug can cause side effects like low blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Sep 2020

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS cardiovascular disorder diastolic heart failure HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure with preserved ejection fraction HIV/AIDS

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.