NCT05828719 Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction
| NCT ID | NCT05828719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2023-06-16 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2023-06-16 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.
Eligibility 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.
Contact & Investigator
Young Bin Song, MD, PhD
STUDY CHAIR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT05828719 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05828719 currently recruiting?
Yes, NCT05828719 is actively recruiting participants. Contact the research team at youngbien.song@samsung.com for enrollment information.
Where is the NCT05828719 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05828719 clinical trial?
NCT05828719 is sponsored by Samsung Medical Center. The principal investigator is Young Bin Song, MD, PhD at Samsung Medical Center. The trial plans to enroll 900 participants.
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