Medical vs Surgical Treatments for Heart Failure
(ISCHEMIA-HF Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byS. Bangalore, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for people with multivessel coronary artery disease and a heart pumping strength (ejection fraction) of 40% or less. It's not specified who can't join, but typically those with other serious health issues or conditions that could interfere with the study might be excluded.

Inclusion Criteria

My heart condition can be treated with stenting or bypass surgery.

My heart's pumping ability is below 40% as shown in recent tests.

I am willing to follow all study requirements, including treatments and check-ups.

+2 more

Exclusion Criteria

I have not had severe heart failure or shock in the last 2 days.

I have dementia and cannot make medical decisions.

History of noncompliance with medical therapy

+5 more

Participant Groups

The ISCHEMIA-HF trial is testing three approaches to treat heart problems caused by narrowed arteries: medical therapy alone, surgery to bypass blocked vessels (CABG), and a non-surgical procedure to open arteries (PCI). Participants are randomly assigned in specific ratios to each treatment group.

3Treatment groups

Experimental Treatment

Group I: PCIExperimental Treatment1 Intervention

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive PCI.

Group II: GDMTExperimental Treatment1 Intervention

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive GDMT.

Group III: CABGExperimental Treatment1 Intervention

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive CABG.

Coronary artery bypass grafting (CABG) is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Coronary artery bypass grafting for: