Clinical trial NCT03238755: Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: a Cardiac MRI Study
Official title: Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: a Cardiac MRI Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infections
Keywords: HIV
Diastolic Dysfunction
Myocardial fibrosis
Statin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institutes of Health (NIH)
First posted: 2017-08-03
Enrollment: 129
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected subjects on ART from the community

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.


Eligibility 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

Primary outcomes:
measure: Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI
timeFrame: Two years
Secondary outcomes:
measure: Diastolic function on Cardiac MRI
timeFrame: Two years
Other outcomes:
measure: Myocardial Inflammation on Cardiac MRI
timeFrame: Two Years
measure: Intramyocardial fat on Cardiac MRI/MRS
timeFrame: Two Years
measure: Diastolic function on Cardiac MRI
timeFrame: Two Years
measure: Visceral Adiposity on MRS
timeFrame: Two Years
measure: Biomarkers (inflammation/ immune markers, hormonal markers) and markers of myocardial stretch
timeFrame: Two Years
Locations:
city: Los Angeles
country: United States
facility: VA Medical Center-Los Angeles
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Dallas
country: United States
facility: UTSW Medical Center
state: Texas
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
References:
citation: Neilan TG, Nguyen KL, Zaha VG, Chew KW, Morrison L, Ntusi NAB, Toribio M, Awadalla M, Drobni ZD, Nelson MD, Burdo TH, Van Schalkwyk M, Sax PE, Skiest DJ, Tashima K, Landovitz RJ, Daar E, Wurcel AG, Robbins GK, Bolan RK, Fitch KV, Currier JS, Bloomfield GS, Desvigne-Nickens P, Douglas PS, Hoffmann U, Grinspoon SK, Ribaudo H, Dawson R, Goetz MB, Jain MK, Warner A, Szczepaniak LS, Zanni MV. Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S63-S69. doi: 10.1093/infdis/jiaa245.