Comparing revascularization and medical treatment for heart failure with reduced ejection fraction
Randomized Controlled Trial of Revascularization Versus Medical Treatment on Clinical Outcomes in Patients With Reduced Left Ventricular Function
This study is testing if opening blocked arteries with a procedure helps people with heart failure feel better compared to just taking medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05828719 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with stage C heart failure and left ventricular ejection fraction less than 40%, who have significant coronary artery stenosis and inducible myocardial ischemia.
Not a fit: Patients who have had a recent myocardial infarction, non-viable myocardium, or lesions not suitable for PCI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for patients with ischemic cardiomyopathy, potentially improving their heart function and quality of life.
How similar studies have performed: Previous studies, such as the REVIVED trial, have shown mixed results regarding the benefits of PCI in similar patient populations, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.