← Back to Search

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

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
Select...
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:
Select...
I have dementia and cannot make medical decisions.
Select...
I need surgery for a serious heart valve problem.
Select...
I have had heart surgery in the past.
Select...
I have not had a stroke or brain bleed in the last 6 months.

Timeline

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

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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
860,642 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
15,178 Patients Enrolled for Coronary Artery Disease
S. Bangalore, MDPrincipal InvestigatorNYU Langone Health
~800 spots leftby Dec 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top