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HIVNCT02874703

Mechanisms of Diastolic Dysfunction Among Persons With HIV Compared With Non-HIV Control Subjects

An observational study of HIV and Diastolic Dysfunction, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, investigators plan to test two potential mechanisms contributing to diastolic dysfunction among asymptomatic persons with HIV who are on cART. The first proposed mechanism is that heightened systemic immune activation/inflammation in HIV contributes to myocardial inflammation, which in turn promotes… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
HIV, Diastolic Dysfunction, Myocardial Fibrosis
What is being tested?
Cardiac MRI/MRS
How many people
48 participants
Where
1 siteUnited States
Study dates
Aug 2016to Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: HIV positive and HIV negative participants

Who may be able to join

  • age ≥40 and ≤75 years
  • documented HIV infection
  • participant report that combination antiretroviral therapy (cART) (any regimen) has been taken stably without > 4 week interruption for at least 180 days prior to study entry (report of switching regimens in that time frame is permissible)
  • age ≥40 and ≤75 years

Who cannot join

  • CD4 < 100 cell/mm3
  • current active AIDS-defining illness
  • current active or recent (not fully resolved within 30 days prior to study entry) systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human papillomavirus [HPV], or HCV)
  • current active cancer
  • clinical ASCVD, as defined by 2013 ACC/AHA guidelines (including previous diagnosis of AMI, ACS, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, PAD), by subject report
  • clinical diagnosis of HFpEF or HFrEF, by subject report
Show all 28Show fewer
  • diagnosed DM on antihyperglycemic medication
  • current, active use of immune suppressant medication including oral or intravenous corticosteroid or injectable biologic (oral ASA or NSAID use permitted)
  • eGFR <45 ml/min/1.73 m2 calculated by CDK-EPI
  • standard contraindications to MRI procedure based on MGH MRI Patient Procedure Screening Form - including history of severe allergy to gadolinium
  • use of lipid lowering agents including statin drugs, fibrates, ezetimibe, red yeast rice, niacin or omega-3 fatty acids (>3 grams/day in standalone formulations) in the 90 days prior to study entry
  • use of ACE inhibitor, ARB, or aldosterone receptor blocker in the 90 days prior to study entry
  • pregnancy or breastfeeding (female subjects of reproductive potential)
  • other medical, psychiatric, or psychological condition that, in the opinion of the study investigator, would interfere with completion of study procedures
  • HIV negative subjects:
  • HIV infection
  • current active or recent (not fully resolved within 30 days prior to study entry) systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human papillomavirus [HPV], or HCV)
  • current active cancer
  • clinical ASCVD, as defined by 2013 ACC/AHA guidelines (including previous diagnosis of AMI, ACS, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, PAD), by subject report
  • clinical diagnosis of HFpEF or HFrEF, by subject report
  • diagnosed DM on antihyperglycemic medication
  • current, active use of immune suppressant medication including oral or intravenous corticosteroid or injectable biologic (oral ASA or NSAID use permitted)
  • eGFR <45 ml/min/1.73 m2 calculated by CDK-EPI
  • standard contraindications to MRI procedure based on MGH MRI Patient Procedure Screening Form - including history of severe allergy to gadolinium
  • use of lipid lowering agents including statin drugs, fibrates, ezetimibe, red yeast rice, niacin or omega-3 fatty acids (>3 grams/day in standalone formulations) in the 90 days prior to study entry
  • use of ACE inhibitor, ARB, or aldosterone receptor blocker in the 90 days prior to study entry
  • pregnancy or breastfeeding (female subjects of reproductive potential)
  • other medical, psychiatric, or psychological condition that, in the opinion of the study investigator, would interfere with completion of study procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

In this study, investigators plan to test two potential mechanisms contributing to diastolic dysfunction among asymptomatic persons with HIV who are on cART. The first proposed mechanism is that heightened systemic immune activation/inflammation in HIV contributes to myocardial inflammation, which in turn promotes myocardial fibrosis. The second mechanism is that ectopic fat deposition (increased visceral adiposity) in HIV relates to increased intramyocardial lipid content, which in turn contributes to diastolic dysfunction. Both HIV positive and HIV-negative participants will undergo cardiac MRI/ MRS imaging studies for evaluation of myocardial fibrosis, myocardial inflammation, and intramyocardial lipid content. Traditional markers of CVD risk, inflammatory markers/immune, hormonal markers, and markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS outcomes. Additionally, a small subset of participants with HIV will undergo longitudinal evaluations to assess effects of a clinically prescribed hormonal therapy on myocardial structure and function.

Being tested
Cardiac MRI/MRS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac MRI/MRSOther

Study groups in NCT02874703
Study groupRoleWhat they receive
HIV-positiveNot described
Receives: Other: Cardiac MRI/MRS
HIV-negativeNot described
Receives: Other: Cardiac MRI/MRS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI

    Measured: 3 weeks

Secondary outcomes (7)

  1. Myocardial Inflammation on Cardiac MRI

    Measured: 3 weeks

  2. Intramyocardial fat on Cardiac MRI/MRS

    Measured: 3 weeks

  3. Diastolic function on Cardiac MRI

    Measured: 3 weeks

  4. Visceral Adiposity on MRI

    Measured: 3 weeks

  5. Inflammation/ immune markers

    Measured: 3 weeks

  6. Hormonal markers

    Measured: 3 weeks

  7. Markers of myocardial stretch

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2019
  4. Study completionAug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874703
Sponsor's protocol ID
2015P000200
Status last verified
Oct 2019
First submitted
12 Aug 2016
Last updated
15 Oct 2019
Results posted
No

Publications

  • Toribio M, Awadalla M, Drobni ZD, Quinaglia T, Wang M, Durbin CG, Alagpulinsa DA, Fourman LT, Suero-Abreu GA, Nelson MD, Stanley TL, Longenecker CT, Burdo TH, Neilan TG, Zanni MV. Cardiac strain is lower among women with HIV in relation to monocyte activation. PLoS One. 2022 Dec 30;17(12):e0279913. doi: 10.1371/journal.pone.0279913. eCollection 2022.

    PubMed 36584183

  • Masenga SK, Romanelli A, Kooij KW. Plasma osteopontin in persons with HIV and the risk for cardiovascular disease. AIDS. 2023 Feb 1;37(2):355-357. doi: 10.1097/QAD.0000000000003445. No abstract available.

    PubMed 36541647

  • Robinson JA, Toribio M, Quinaglia T, Awadalla M, Talathi R, Durbin CG, Alhallak I, Alagpulinsa DA, Fourman LT, Suero-Abreu GA, Nelson MD, Stanley TL, Longenecker CT, Szczepaniak LS, Jerosch-Herold M, Neilan TG, Zanni MV, Burdo TH. Plasma osteopontin relates to myocardial fibrosis and steatosis and to immune activation among women with HIV. AIDS. 2023 Feb 1;37(2):305-310. doi: 10.1097/QAD.0000000000003417. Epub 2022 Nov 3.

    PubMed 36541642

  • Toribio M, Fulda ES, Chu SM, Drobni ZD, Awadalla M, Cetlin M, Stanley TL, North CM, Nelson MD, Jerosch-Herold M, Szczepaniak LS, Burdo TH, Looby SE, Neilan TG, Zanni MV. Hot Flashes and Cardiovascular Disease Risk Indices Among Women With HIV. Open Forum Infect Dis. 2021 Jan 12;8(2):ofab011. doi: 10.1093/ofid/ofab011. eCollection 2021 Feb.

    PubMed 33575428

  • Toribio M, Awadalla M, Cetlin M, Fulda ES, Stanley TL, Drobni ZD, Szczepaniak LS, Nelson MD, Jerosch-Herold M, Burdo TH, Neilan TG, Zanni MV. Brief Report: Vascular Dysfunction and Monocyte Activation Among Women With HIV. J Acquir Immune Defic Syndr. 2020 Oct 1;85(2):233-238. doi: 10.1097/QAI.0000000000002419.

    PubMed 32541385

  • Zanni MV, Awadalla M, Toribio M, Robinson J, Stone LA, Cagliero D, Rokicki A, Mulligan CP, Ho JE, Neilan AM, Siedner MJ, Triant VA, Stanley TL, Szczepaniak LS, Jerosch-Herold M, Nelson MD, Burdo TH, Neilan TG. Immune Correlates of Diffuse Myocardial Fibrosis and Diastolic Dysfunction Among Aging Women With Human Immunodeficiency Virus. J Infect Dis. 2020 Mar 28;221(8):1315-1320. doi: 10.1093/infdis/jiz184.

    PubMed 31100122

Questions about this trial

What is this clinical trial studying?

An observational study of HIV and Diastolic Dysfunction, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02874703, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

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