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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CTO-PCI
Procedure/SurgeryPercutaneous coronary intervention (PCI) of a coronary chronic total occlusion (CTO) (CTO-PCI) in patients with systolic heart failure (LVEF \<50%).
Treatment groups
783 Participants
are divided into 2 treatment groupsGroup A: CTO-PCIExperimental treatment 1 intervention
Group B: non-CTO-PCINo intervention 0 interventions
Trial outcomes
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
Time frame
up to 3 yearsSecondary outcomes
1
Canadian cardiovascular society (CCS) class
angina pectoris
Time frame
up to 3 years2
All-cause mortality.
Time frame
up to 3 years3
Heart failure related rehospitalization.
Time frame
up to 3 years4
MACCE
MACCE are defined as the composite of all-cause death, myocardial infarction (type I and II), any further type of coronary revascularization (i.e. PCI or CABG) based on functional invasive assessment by fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR), and stroke.
Time frame
up to 3 yearsLocations
Sponsors and contacts
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Universitätsmedizin Mannheim
Lead sponsor
Herzzentrum Lahr
Collaborator
IHF GmbH - Institut für Herzinfarktforschung
Collaborator
Source ClinicalTrials.gov
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