Comparing revascularization and medical treatment for heart failure with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the clinical outcomes of patients with ischemic cardiomyopathy and left ventricular dysfunction who receive either revascularization through percutaneous coronary intervention (PCI) or guideline-directed medical treatment alone. The study is based on the premise that restoring blood flow to the heart muscle may improve heart function and overall health outcomes. Participants will be randomized to receive one of the two treatment approaches, and their progress will be monitored to assess the effectiveness of each method. The trial seeks to clarify the role of PCI in patients with significant coronary artery disease and reduced ejection fraction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject must be at least 19 years of age
* Patients with stage C heart failure and left ventricular ejection fraction\<40%
* Patients with significant coronary artery stenosis (diameter stenosis\>50% with proven inducible myocardial ischemia by invasive physiologic assessment)
* Coronary artery disease is amenable for percutaneous coronary intervention (PCI)
* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria:

* Myocardial infarction by universal definition within 4 weeks of randomization
* Non-viable myocardium in myocardial viability test (cardiac magnetic resonance, dobutamine-stress echocardiography, delayed single-photon emission computerized tomography, or aneurysmal change in echocardiography)
* Target lesions not amenable for PCI by operators' decision
* Patients who need left ventricular assisted device (LVAD) or heart transplantation at the time of randomization
* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
* Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
* Pregnancy or breast feeding
* Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Unwillingness or inability to comply with the procedures described in this protocol.

Where it's running

• Samsune Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Young Bin Song, MD, PhD — Samsung Medical Center
• Study coordinator: Young Bin Song, MD, PhD
• Email: youngbien.song@samsung.com
• Phone: 82-2-3410-6653

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.