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Angiotensin Receptor-Neprilysin Inhibitor
Sacubitril-Valsartan for Heart Failure in HIV
Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Antiretroviral therapy use for >12 months
Be older than 18 years old
Must not have
Creatinine (Cr)>1.5 mg/dL and estimated GFR<60 mL/min/1.73m2
Known liver disease or ALT>3x upper limit normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial is testing a medication called sacubitril/valsartan in people with HIV who show early signs of heart changes. The medication aims to block a harmful hormone and increase a protective one to prevent heart problems. The study will see if this treatment can improve heart health in these patients.
Who is the study for?
This trial is for people with HIV who've been on antiretroviral therapy for over a year, have controlled viral loads, and show early signs of heart issues but no recent severe cardiac events or uncontrolled diabetes. They shouldn't be pregnant, seeking pregnancy, breastfeeding, or using certain hormones and must not have liver disease or be on medications that affect the same pathways as the study drugs.
What is being tested?
The ENCHANTMENT HIV Study tests if Sacubitril/Valsartan can help prevent heart failure in those with HIV by blocking harmful hormones and improving heart function. Participants will either receive this medication or a placebo without knowing which one they're taking to compare effects fairly.
What are the potential side effects?
Sacubitril/Valsartan may cause low blood pressure, high potassium levels, kidney problems, dizziness upon standing up too fast (orthostatic hypotension), coughing, and swelling around the eyes (angioedema). These side effects are not guaranteed but possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on antiretroviral therapy for more than a year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced with creatinine over 1.5 mg/dL and GFR under 60.
Select...
My liver isn't working well, or my ALT levels are high.
Select...
My diabetes is not under control and I need insulin or my HbA1c is above 7.5%.
Select...
I am currently fighting an infection.
Select...
I have not had a heart attack or stroke in the last 3 months.
Select...
I am taking medication that might not mix well with the study drug.
Select...
I have a history of heart failure or heart valve disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Myocardial Dysfunction
Myocardial Inflammation/Fibrosis
Secondary study objectives
Cardiac Natriuretic Peptides
Markers of Myocardial Inflammation and Fibrosis
Other Indices of Myocardial Dysfunction
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sacubitril/ValsartanExperimental Treatment1 Intervention
Sacubitril/Valsartan 49-51mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart failure, such as aldosterone blockers and BNP enhancers, work by targeting key hormonal pathways. Aldosterone blockers reduce inflammation and stress on the heart by inhibiting aldosterone, which can cause fluid retention and high blood pressure.
BNP enhancers increase brain natriuretic peptide levels, aiding in blood vessel relaxation, reducing fluid buildup, and improving heart function. These treatments are vital for heart failure patients as they help manage symptoms, slow disease progression, and enhance cardiovascular health.
Aldosterone as a mediator in cardiovascular injury.
Aldosterone as a mediator in cardiovascular injury.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,232 Total Patients Enrolled
51 Trials studying Heart Failure
212,917 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's ability to squeeze and relax is less than 18%.My kidney function is reduced with creatinine over 1.5 mg/dL and GFR under 60.Your heart is too big for your body size.Your blood pressure is less than 100 mmHg.Your blood potassium level is higher than 5.5 milliequivalents per liter.You have had a bad reaction to gadolinium in the past.Your left atrium is too big for this study.You have had a serious allergic reaction to ACE inhibitors or ARBs.My liver isn't working well, or my ALT levels are high.Your HIV viral load must be less than 200 copies/mL.You are currently using drugs or alcohol in a way that is harmful.My diabetes is not under control and I need insulin or my HbA1c is above 7.5%.I am currently fighting an infection.I am currently taking medication for blood pressure or potassium supplements.I haven't used estrogen, progestin, or other sex steroids in the last 3 months.I have not had a heart attack or stroke in the last 3 months.I am taking medication that might not mix well with the study drug.I have been on antiretroviral therapy for more than a year.Your heart's pumping ability is lower than 50%.Your hemoglobin level is less than 10.0 grams per deciliter.I have a history of heart failure or heart valve disease.You have signs of heart problems on a heart ultrasound that show a specific type of heart failure.I have not taken steroids in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Sacubitril/Valsartan
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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