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NCT07349979

PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1154

Start Date

2026-12-30

Completion Date

2028-01-30

Last Updated

2026-05-28

Healthy Volunteers

Conditions

Heart Failure With Reduced Ejection Fraction Coronary Artery Disease Stable GDMT

Interventions

PROCEDURE

Percutaneous coronary intervention

PCI will be performed according to standard techniques. Use of a contemporary, FDA/CE-approved drug-eluting stent is mandatory.

DRUG

Guideline-directed medical therapy

GDMT optimization follows a structured titration algorithm: Week 0: introducing angiotensin-converting enzyme inhibitor (ACEi)/ angiotensin II receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitors (ARNI) and beta-blockers. Week 1: adding mineralocorticoid receptor antagonist (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i). Adjust every 2-4 weeks to reach target or tolerable dose unless symptomatic hypotension (systolic blood pressure \[SBP\] \< 90 mmHg) or estimated glomerular filtration rate (eGFR) drop \> 30 % or serum potassium \>5.2 mmol/L.

Inclusion Criteria: 1. Age ≥18 years at screening. 2. Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization. 3. 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/mL. 4. 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 \<90%, 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. 5. On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site. 6. 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. Exclusion Criteria: 1. Class III or IV angina requiring revascularization. 2. Any unplanned hospitalization within 30 days. 3. Any PCI within 12 months. 4. Any prior CABG. 5. Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate) 6. Non-cardiac life expectancy \<1 year at screening (e.g., malignancy, advanced liver disease). 7. Coronary anatomy requiring surgical revascularization by local heart team determination. 8. Coronary anatomy unsuitable for PCI. 9. HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM). 10. Severe stenosis or regurgitation of any heart valve. 11. Contraindication to dual antiplatelet therapy or iodinated contrast. 12. 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. 13. Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol. 14. 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.

Locations (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China