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

Phase 3

Waitlist Available

Led By S. Bangalore, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Dementia with loss of capacity to consent (clinically evident or previously diagnosed)

Concomitant significant valvular heart disease requiring surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial will enroll patients with heart disease and weak heart function to compare three different treatment options: medication, bypass surgery, and heart stenting."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to medications such as bleeding, kidney issues, or allergic responses; surgical risks from CABG like infection and stroke; and complications from PCI like blood vessel damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart scan shows severe blockage in multiple arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have dementia and cannot make medical decisions.

Select...

I need surgery for a serious heart valve problem.

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I have had heart surgery in the past.

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I have not had a stroke or brain bleed in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Cognitive Score

Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF

Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

Secondary study objectives

Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause

Composite Number of: Death or Hospitalization for HF

Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Coronary artery bypass grafting (CABG)

1997

N/A

~560

0 / 5Eligibility criteria met