NCT07349979

PCI With Guideline-Directed Medical Therapy for HFpEF Patients With Ischemic Cardiomyopathy

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 654 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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) through 12 months in patients with ischemic cardiomyopathy and a left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular \[CV\] death, spontaneous myocardial infarction (MI), any unplanned revascularization, heart failure (HF)-related rehospitalization, heart transplantation, requirement of device implantation (e.g., valvular treatment, pacemaker, or left ventricular assist device \[LVAD\]), or requirement of intravenous medications due to worsening heart failure in outpatients.

Detailed description

A prospective, randomized, controlled, open-label, multicenter trial with blinded endpoint adjudication (PROBE design). A total of 654 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 a 1:1 ratio to: Experimental Group: PCI with contemporary DES plus GDMT Control Group: GDMT only Angiographically proven CAD is defined as a visually estimated diameter stenosis (DS) \<90% with a quantitative flow ratio (QFR) ≤0.80 in a major epicardial vessel (reference vessel diameter \[RVD\] ≥2.5 mm), which is deemed amenable to successful PCI with DES by an interventional cardiologist. Complete revascularization of all angiographically significant lesions (visually estimated stenosis ≥70% in vessels with RVD ≥2.5 mm) is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days. Both arms receive optimized GDMT according to current guidelines. Given the nature of the intervention (PCI vs. no PCI), treating physicians and patients cannot be blinded. To minimize bias, a PROBE design is employed with a blinded independent Clinical Events Committee (CEC), blinded core laboratories, and blinded statisticians. The catheterization laboratory team is unblinded but not involved in follow-up decisions or endpoint assessments. Clinic/telephone follow-up is conducted at 30 days and 3, 6, 9, and 12 months, with annual passive follow-up to 24 months.

Conditions

• Heart Failure With Reduced Ejection Fraction
• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-12-30
• Primary completion: 2028-01-30
• Completion: 2028-01-30
• First posted: 2026-01-20
• Last updated: 2026-04-13

Locations

1 site across 1 country: China