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Trial record 3 of 10 for:    lcz696 mri

Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)

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ClinicalTrials.gov Identifier: NCT04153136
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Suman Srinivasa, M.D., Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 30, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date October 15, 2021
Actual Study Start Date  ICMJE September 11, 2020
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2019)
  • Myocardial Inflammation/Fibrosis [ Time Frame: 6 months ]
    Myocardial Inflammation/Fibrosis measured by extracellular volume fraction via cardiac magnetic resonance imaging
  • Left Atrial Volume Index [ Time Frame: 6 months ]
    Left Atrial Volume Index measured by cardiac transthoracic echocardiography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2019)
  • Indices of Myocardial Dysfunction [ Time Frame: 6 months ]
    Alterations in other cardiac structure and function as measured by cardiac magnetic resonance imaging or cardiac transthoracic echocardiogram
  • Markers of Myocardial Inflammation and Fibrosis [ Time Frame: 6 months ]
    Circulating biomarkers of myocardial inflammation and fibrosis: Gal3, ST2, GDF15, hs-cTnT
  • Cardiac Natriuretic Peptides [ Time Frame: 6 months ]
    Circulating cardiac natriuretic peptides: ANP, BNP, NT-proBNP
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)
Official Title  ICMJE Ending Subclinical Heart Failure Using an Aldosterone and Natriuretic Peptide Targeted Treatment in HIV--The ENCHANTMENT HIV Study
Brief Summary 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.
Detailed Description This is a 6-month study enrolling persons with HIV with no known history of heart disease. Participants will be screened for early signs of heart failure using cardiac ultrasound (cardiac transthoracic echocardiography or cardiac TTE). Those participants who have early changes in the structure and function of the heart and may be at future risk for heart failure will be enrolled into the study. Additional imaging of the heart will occur using cardiac magnetic resonance imaging (cardiac MRI). Following baseline studies, participants will either receive a medication called sacubitril/valsartan or placebo for 6 months. Sacubitril/valsartan in an FDA approved medication currently being used for heart failure with reduced ejection fraction in the general population, and we are evaluating whether this medication could be useful to reduce HIV-related heart failure with preserved ejection fraction. Sacubitril/valsartan is an oral medication taken twice daily that may block aldosterone hormone and increase natriuretic peptide hormone. Overall, this study aims to investigate the effect of sacubitril/valsartan on measures of heart disease related to inflammation, structure and function of the heart muscle in HIV using cardiac TTE and cardiac MRI imaging as well as blood markers of heart failure and inflammation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV/AIDS
  • Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE
  • Drug: Sacubitril-Valsartan 49-51Mg Oral Tablet
    By mouth twice daily
    Other Name: Entresto
  • Drug: Placebo oral tablet
    Placebo oral tablet By mouth twice daily
Study Arms  ICMJE
  • Experimental: Sacubitril/Valsartan
    Sacubitril/Valsartan 49-51mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months
    Intervention: Drug: Sacubitril-Valsartan 49-51Mg Oral Tablet
  • Placebo Comparator: Placebo
    Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months
    Intervention: Drug: Placebo oral tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Antiretroviral therapy use for >12 months
  2. HIV Viral Load <200 copies/mL
  3. Increased waist circumference based on NCEP criteria (male>102cm2 and female>88cm2) or increased waist to hip ratio based on WHO criteria (male>0.95 and female>0.80)
  4. Left Ventricular Ejection Fraction>50%
  5. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suman Srinivasa, MD, MS 6177269109 ssrinivasa@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04153136
Other Study ID Numbers  ICMJE MGH2019P002355
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suman Srinivasa, M.D., Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP