Status:
NOT_YET_RECRUITING
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
Lead Sponsor:
NYU Langone Health
Conditions:
Coronary Artery Disease
Cognitive Impairment
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
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):corona...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06566183
Start Date
December 1 2026
End Date
December 1 2032
Last Update
July 3 2025
Active Locations (6)
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1
NYU Langone Health
New York, New York, United States, 10016
2
International Study Site
International Study Site, Brazil
3
International Study Site
International Study Site, India
4
International Study Site
International Study Site, Mexico