[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619850":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":61,"collaborators":42,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":42,"enrollmentInfo":74,"targetDuration":42,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":88,"whyStopped":42,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PCI with contemporary DES + GDMT","ACTIVE_COMPARATOR","A total of 1154 patients with LVEF ≤40%, angiographically proven coronary artery disease (CAD) amenable to PCI, and symptomatic heart failure (NYHA Class II-IV) on stable GDMT，will be assigned at 1:1 ratio to two arms.\n\nAngiographically proven CAD is defined as 1) a visually estimated diameter stenosis (DS) of ≥90%, or 2) a chronic total occlusion with a high likelihood (\\>80%) of PCI success, or 3) a visually estimated diameter stenosis (DS) of \\\u003C90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions are considered amenable to PCI with DES by an interventional cardiologist.\n\nRandomization will be stratified by the presence of planned CTO PCI, planned left main PCI and center.\n\nComplete revascularization of all angiographically significant lesions is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days.",[13,14],"Procedure: Percutaneous coronary intervention","Drug: Guideline-directed medical therapy",{"label":16,"type":10,"description":17,"interventionNames":18},"GDMT only","The control group will receive GDMT; this is approved treatments for preventing HF that could be utilised as a comparator. All patients will be treated according to local guidelines on standard of care treatment for patients with HFrEF and post PCI, focusing on treatment of HF symptoms (e.g. diuretics) and comorbidities (including treatment for high blood pressure, ischaemic heart disease).",[14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Percutaneous coronary intervention","PCI will be performed according to standard techniques. Use of a contemporary, FDA\u002FCE-approved drug-eluting stent is mandatory.",[9],[26],"PCI",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Guideline-directed medical therapy","GDMT optimization follows a structured titration algorithm:\n\nWeek 0: introducing angiotensin-converting enzyme inhibitor (ACEi)\u002F angiotensin II receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitors (ARNI) and beta-blockers.\n\nWeek 1: adding mineralocorticoid receptor antagonist (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i).\n\nAdjust every 2-4 weeks to reach target or tolerable dose unless symptomatic hypotension (systolic blood pressure \\[SBP\\] \\\u003C 90 mmHg) or estimated glomerular filtration rate (eGFR) drop \\> 30 % or serum potassium \\>5.2 mmol\u002FL.",[16,9],[33],"GDMT",[35],{"name":36,"affiliation":5,"role":37},"Shao-Liang Chen, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+86-25-52271351",null,"chmengx@126.com",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Jing Kan, PhD","+86-25-52279862","kanjingok@126.com",[49],{"facility":5,"status":42,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":42},"Nanjing","Jiangsu","210006","China","CN",{"type":56,"coordinates":57},"Point",[58,59],118.77778,32.06167,{"lat":59,"lon":58},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Shaoliang Chen, MD","Principal Investigator","100619850","pci-with-gdmt-versus-gdmt-alone-for-patients-with-ischemic-cardiomyopathy-and-reduced-lvef-100619850",false,"NCT07349979","PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF","Percutaneous Coronary Intervention With Guideline-Directed Medical Therapy Versus Guideline-Directed Medical Therapy Alone for Patients With Ischemic Cardiomyopathy and Reduced Left Ventricular Ejection Fraction: A Randomized, Controlled, Open-Label, Multicenter PCI-GULF Trial","PCI-GULF","Inclusion Criteria:\n\n1. Age ≥18 years at screening.\n2. Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization.\n3. Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg\u002FmL.\n4. Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (\\>80%) of PCI success, or 3) a visually estimated DS of \\\u003C90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist.\n5. On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site.\n6. The subject, or their legal guardian, has a clear understanding of the trial's design and procedures, provide written informed consent, and is able to comply with all follow-up procedures.\n\nExclusion Criteria:\n\n1. Class III or IV angina requiring revascularization.\n2. Any unplanned hospitalization within 30 days.\n3. Any PCI within 12 months.\n4. Any prior CABG.\n5. Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate)\n6. Non-cardiac life expectancy \\\u003C1 year at screening (e.g., malignancy, advanced liver disease).\n7. Coronary anatomy requiring surgical revascularization by local heart team determination.\n8. Coronary anatomy unsuitable for PCI.\n9. HF due to specific cardiomyopathies, including restrictive\u002Finfiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM).\n10. Severe stenosis or regurgitation of any heart valve.\n11. Contraindication to dual antiplatelet therapy or iodinated contrast.\n12. Pregnancy, lactation, or women of childbearing potential not using effective contraception. A negative urine pregnancy test is required within 7 days prior to randomization for women of childbearing potential.\n13. Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.\n14. Any other circumstances that the investigator deems inappropriate for participation, including but not limited to conditions that may jeopardize patient safety, confound data interpretation, or patients unlikely to comply with study procedures.","ALL","18 Years",{"count":75,"type":76},1154,"ESTIMATED","INTERVENTIONAL",[79],"NA","To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months, measured at the time the last enrolled patient reaches 12 months, in patients with ischemic cardiomyopathy and left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular \\[CV\\] death, myocardial infarction (MI), heart failure (HF) related rehospitalization, heart transplantation, requirement for durable left ventricular assist device \\[LVAD\\] implantation, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications.",[82,83,84],"Heart Failure With Reduced Ejection Fraction","Coronary Artery Disease","Stable GDMT",[86,26,33,87],"HFrEF","MACE","NOT_YET_RECRUITING","2026-05-24",{"date":91,"type":92},"2026-05-28","ACTUAL",{"date":94,"type":76},"2026-12-30",{"date":96,"type":76},"2028-01-30",{"name":5,"class":6},1]