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

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Apr 23, 2026 to Feb 23, 2028 Interventions: Cardiac MRI/MRS (Other) to Cardiac MRI/MRS (Other) · Publications: details revised at 1 of 1 entry · Eligibility criteria expanded, about 3 words Show 3 more changesShow less
    • Interventions: Cardiac MRI/MRS (Other) to Cardiac MRI/MRS (Other)
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 3 words
  2. Completion date: Apr 23, 2024 to Apr 23, 2026v10
  3. Completion date: Apr 2024 to Apr 23, 2024v9
  4. Primary completion date changed from estimate of Apr 2022 to Jun 22, 2022 Completion date: Apr 2022 to Apr 2024v8 Show 1 more changeShow less
    • Completion date: Apr 2022 to Apr 2024
  5. Primary and study completion dates: Apr 2021 to Apr 2022v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Jul 2020 to Apr 2021v6
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 130 to confirmed 129 · Site details revised at 4 of 4 sitesv5 Show 2 more changesShow less
    • Enrollment target: estimated 130 to confirmed 129
    • Site details revised at 4 of 4 sites
  3. Study sites: 3 to 4v4
  4. Study sites: 2 to 3v3
  5. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03238755
Lead Sponsor Massachusetts General Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
Conditions HIV Infections
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov