CTO-PCI in Heart Failure Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversitätsmedizin Mannheim
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- CTO-PCI
Treatment groups
783 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Universitätsmedizin Mannheim
Lead sponsor
Herzzentrum Lahr
Collaborator
IHF GmbH - Institut für Herzinfarktforschung
Collaborator
Source ClinicalTrials.gov