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Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03238755
Recruitment Status : Active, not recruiting
First Posted : August 3, 2017
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Tomas G. Neilan, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
In this study, investigators plan to test whether statins can preserve and/or improve diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy. Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial steatosis prior to initiation of statin or placebo therapy and then two years after initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk, systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS outcomes.

Condition or disease Intervention/treatment
HIV Infections Other: Cardiac MRI/MRS

Study Design
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Study Type : Observational
Actual Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Statin group
HIV-infected individuals receiving statin therapy for the duration of the study
 Other: Cardiac MRI/MRS
whole blood, plasma, and serum
Placebo group
HIV-infected individuals receiving placebo therapy for the duration of the study
 Other: Cardiac MRI/MRS
whole blood, plasma, and serum


Outcome Measures
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Primary Outcome Measures :
  1. Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Diastolic function on Cardiac MRI [ Time Frame: Two years ]

Other Outcome Measures:
  1. Myocardial Inflammation on Cardiac MRI [ Time Frame: Two Years ]
  2. Intramyocardial fat on Cardiac MRI/MRS [ Time Frame: Two Years ]
  3. Diastolic function on Cardiac MRI [ Time Frame: Two Years ]
  4. Visceral Adiposity on MRS [ Time Frame: Two Years ]
  5. Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch [ Time Frame: Two Years ]

Biospecimen Retention:   Samples Without DNA
whole blood, plasma, and serum

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected subjects on ART from the community
Criteria

Inclusion Criteria:

  • New enrollment in the REPRIEVE Trial

Exclusion Criteria:

  • clinical diagnosis of HFpEF or HFrEF, by subject report
  • standard contraindications to MRI procedure based on MRI Patient Procedure Screening Form - including history of severe allergy to gadolinium
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238755


Locations
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United States, California
VA Medical Center-Los Angeles
Los Angeles, California, United States, 90073
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
UTSW Medical Center
Dallas, Texas, United States, 75235
South Africa
University of Cape Town
Cape Town, South Africa
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tomas G. Neilan, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03238755    
Other Study ID Numbers: 2016P001999
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomas G. Neilan, MD, Massachusetts General Hospital:
HIV
Diastolic Dysfunction
Myocardial fibrosis
Statin
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases