COMPLETED

The ENCHANTMENT HIV Study

Conditions

HIV/AIDS Heart Failure With Preserved Ejection Fraction HIV Sacubitril/valsartan Aldosterone Natriuretic Peptides Myocardial Dysfunction Cardiovascular Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study

Quick Facts

Study Start:2020-09-11

Study Completion:2025-07-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04153136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-11

Study Completion Date2025-07-09

Study Record Updates

Study Start Date2020-09-11

Study Completion Date2025-07-09

Terms related to this study

Keywords Provided by Researchers

HIV
Sacubitril/valsartan
Heart Failure with Preserved Ejection Fraction
Aldosterone
Natriuretic Peptides
Myocardial Dysfunction
Cardiovascular Disease

Additional Relevant MeSH Terms

HIV/AIDS
Heart Failure With Preserved Ejection Fraction