NCT05632653

CTO-PCI in Heart Failure Patients

Percutaneous Coronary Intervention in Patients with Chronic Total Occlusion of Coronary Arteries and Heart Failure.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 783 (estimated)
• Sponsor: Universitätsmedizin Mannheim · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study investigates wheather CTO-PCI improves survival and heart failure related rehospitalization compared to optimal medical therapy (OMT). This hypothesis will be investigated within a large-scaled international, representative, prospective, randomized, controlled, open-label, event-driven, multicentre trial (trial acronym: CTO - Heart Failure) recruiting patients with planned CTO-PCI.

Detailed description

Coronary artery disease (CAD) is the most common cause of heart failure and death worldwide. Beside non-occlusive coronary arterial stenoses, 25% of CAD patients have a so called chronic total occlusion (CTO) at one out of three main coronary arteries. CTO are often left untreated by physicians over many years due to lack of knowledge of its prognostic relevance and due to be too challenging and risky for the interventional cardiologist, particularly in the presence of severe comorbidities such as heart failure. By development of new interventional devices, techniques and algorithms, CTO can be revascularized in more than 90% with low complication rates. Per se, a patient suffering from comorbid heart failure caused by CAD including a CTO is often regarded as inoperable for heart surgery by coronary artery bypass grafting (CABG). Therefore, the only causal alternative therapy represents the less-invasive interventional revascularization of the CTO by percutaneous coronary intervention (PCI). Until now, the prognostic impact of CTO-PCI has never been proven. Our recent work has outlined the beneficial impact of CTO-PCI to improve both left ventricular cardiac function and cardiopulmonary exercise capacity in patients with heart failure. Our objective is to understand whether CTO-PCI improves survival and heart failure related rehospitalization compared to optimal medical therapy (OMT). This hypothesis will be investigated within a large-scaled representative, prospective, randomized, controlled, open-label, event-driven, multicentre trial (trial acronym: CTO - Heart Failure) recruiting patients with planned CTO-PCI. The CTO Heart Failure aims to deliver evidence whether CTO-PCI might become a prognostically relevant established therapeutic option for patients with systolic heart failure.

Conditions

• Coronary Artery Disease
• Chronic Total Occlusion
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	CTO-PCI	Percutaneous coronary intervention (PCI) of a coronary chronic total occlusion (CTO) (CTO-PCI) in patients with systolic heart failure (LVEF \<50%).

Timeline

• Start date: 2025-09-01
• Primary completion: 2030-03-01
• Completion: 2030-12-01
• First posted: 2022-11-30
• Last updated: 2024-09-19