CTO-PCI in Heart Failure Patients

NCT05632653 | Not Yet Recruiting

• 1 other identifier: 01012022-MA
• Study Type: interventional
• Target: 783
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease; Chronic Total Occlusion; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality or heart failure related rehospitalization.

  Heart failure related rehospitalization is defined as a rehospitalization due to worsening heart failure requiring intravenous therapy as the primary cause, or as a result of another cause but associated with worsening heart failure at the time of admission, or as a result of another cause but complicated by worsening heart failure during its course

  up to 3 years

Secondary Outcomes (9)

• Canadian cardiovascular society (CCS) class

  up to 3 years

• All-cause mortality.

  up to 3 years

• Heart failure related rehospitalization.

  up to 3 years

• MACCE

  up to 3 years

• Number of participanty with rehospitalization due to cardiac diseases beyond heart failure.

  up to 3 years

Study Arms (2)

CTO-PCI

EXPERIMENTAL

Procedure: CTO-PCI

non-CTO-PCI

NO INTERVENTION

Interventions

CTO-PCI PROCEDURE

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

CTO-PCI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Presence of at least one CTO located at the proximal to midpart of left artery descending (LAD), or at proximal left circumflex (LCX), or at proximal to midpart LCX in left dominant system, or at proximal to distal right coronary artery (RCA).
• LVEF \<50% (assessed within 6 weeks prior to enrolment by transthoracic echocardiography (TTE) (Simpson biplane method) or cardiac magnetic resonance imaging (cMRI).
• In patients with multivessel disease (MVD) and Syntax I score ≥ 22, and all patients with type 2 diabetes and coronary 3 vessel disease, a heart team decision favouring CTO-PCI is needed.
• Mandatory baseline imaging assessment (assessed within 6 weeks prior to enrolment):
• TTE: Normal wall motion or hypokinesia in the CTO-territory.
• In case of severe hypokinesia, akinesia or dyskinesia a viability testing with cMRI or myocardial scintigraphy (MS) indicating at least 50% of viability in the CTO territory (mandatory only in the presence of akinesia in the CTO-territory assessed by prior TTE) prior to PCI is mandatory.
• Symptoms including dyspnea (according to the New York Heart Association (NYHA), classes II-III) or angina pectoris (according to Canadian Cardiovascular Society (CCS), classes II-IV).
• In the absence of symptoms evidence of myocardial ischemia of at least 10% is needed being assessed by invasive or non-invasive imaging, such as stress-MRI, PET-CT-scan, myocardial scintigraphy, stress-echocardiography

You may not qualify if:

• Age \<18 and \>90 years.
• Akinesia or dyskinesia assessed by TTE plus subendocardial late gadolinium enhancement of \>50% assessed by cMRI or MS in the CTO-territory or any evidence of transmural scarring of the CTO-territory (i.e. 100%).
• Presence of terminal kidney disease with need for renal replacement therapy.
• Severe chronic kidney disease (defined as GFR \< 25 ml/min).
• Type I myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction (STEMI or NSTEMI)) related to critical arteriosclerosis \< 30 days.
• End-stage heart failure (defined by constant administration of intravenous inotropes, use of prolonged assist devices (more than 5 days), listing for high urgent cardiac transplantation).
• Cardiogenic shock (\< 30 days).
• Heart team decision favoring CABG surgery (in the presence of coronary multivessel disease with intermediate to high SYNTAX I score).
• Grade II-III heart valve disorders requiring interventional or surgical treatment within 3 months.
• Right-sided heart failure with echocardiographic evidence of severe right ventricular dysfunction.
• COPD requiring long-term oxygen therapy.
• Non-cardiac comorbidity with life expectancy \< 12 months.

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead
• Herzzentrum Lahr: collaborator
• IHF GmbH - Institut für Herzinfarktforschung: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Michael Behnes, Prof. Dr.

  Universitätsmedizin Mannheim

  PRINCIPAL INVESTIGATOR

• Kambis Mashayekhi, PD Dr.

  MEDICLIN Herzzentrum Lahr

  STUDY DIRECTOR

Central Study Contacts

Michael Behnes, Prof. Dr.

CONTACT

+49 621 383 6239; michael.behnes@umm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: November 30, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share