International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
Paused · Phase 3
Conditions studied: Coronary Artery Disease, Cognitive Impairment, Heart Failure
In brief
The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).
Key facts
- Study ID
- NCT06566183
- Run by
- NYU Langone Health
- People needed
- 1200
- Starts
- 2026-12-01
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-06-05
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
- Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography
- CAD amenable to either PCI or CABG as determined by the local heart team
- Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
- Participant is able and willing to give written informed consent
You may not qualify if…
- Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization
- Concomitant significant valvular heart disease requiring surgery
- Prior cardiac surgery
- Dementia with loss of capacity to consent (clinically evident or previously diagnosed)
- Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
- History of noncompliance with medical therapy
- Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
- Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)
Where it is running
- NYU Langone Health — New York, New York, United States
- International Study Site — International Study Site, Brazil
- International Study Site — International Study Site, India
- International Study Site — International Study Site, Mexico
- International Study Site — International Study Site, Poland
- International Study Site — International Study Site, South Korea
Full record on ClinicalTrials.gov
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