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CTO-PCI in Heart Failure Patients (CTO-HF)

Primary Purpose

Coronary Artery Disease, Chronic Total Occlusion, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CTO-PCI
Sponsored by
Universitätsmedizin Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CTO-PCI

    non-CTO-PCI

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Canadian cardiovascular society (CCS) class
    angina pectoris
    All-cause mortality.
    Heart failure related rehospitalization.
    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.
    Number of participanty with rehospitalization due to cardiac diseases beyond heart failure.
    assessment of quality of life
    Seattle angina questionnaire (SAQ) (0-100; 75-100 normal).
    cost effectivenes
    direct and indirect health care related costs
    Re-assessment of LVEF
    New York Heart association (NYHA) class
    dyspnea

    Full Information

    First Posted
    January 27, 2022
    Last Updated
    November 21, 2022
    Sponsor
    Universitätsmedizin Mannheim
    Collaborators
    Herzzentrum Lahr, IHF GmbH - Institut für Herzinfarktforschung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05632653
    Brief Title
    CTO-PCI in Heart Failure Patients
    Acronym
    CTO-HF
    Official Title
    Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion and Heart Failure.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2028 (Anticipated)
    Study Completion Date
    December 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitätsmedizin Mannheim
    Collaborators
    Herzzentrum Lahr, IHF GmbH - Institut für Herzinfarktforschung

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Chronic Total Occlusion, Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    783 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CTO-PCI
    Arm Type
    Experimental
    Arm Title
    non-CTO-PCI
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    CTO-PCI
    Intervention Description
    Percutaneous coronary intervention (PCI) of a coronary chronic total occlusion (CTO) (CTO-PCI) in patients with systolic heart failure (LVEF <50%).
    Primary Outcome Measure Information:
    Title
    Composite of all-cause mortality or heart failure related rehospitalization.
    Description
    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 years
    Secondary Outcome Measure Information:
    Title
    Canadian cardiovascular society (CCS) class
    Description
    angina pectoris
    Time Frame
    up to 3 years
    Title
    All-cause mortality.
    Time Frame
    up to 3 years
    Title
    Heart failure related rehospitalization.
    Time Frame
    up to 3 years
    Title
    MACCE
    Description
    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 years
    Title
    Number of participanty with rehospitalization due to cardiac diseases beyond heart failure.
    Time Frame
    up to 3 years
    Title
    assessment of quality of life
    Description
    Seattle angina questionnaire (SAQ) (0-100; 75-100 normal).
    Time Frame
    up to 3 years
    Title
    cost effectivenes
    Description
    direct and indirect health care related costs
    Time Frame
    up to 3 years
    Title
    Re-assessment of LVEF
    Time Frame
    up to 3 years
    Title
    New York Heart association (NYHA) class
    Description
    dyspnea
    Time Frame
    up to 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Behnes, Prof. Dr.
    Phone
    +49 621 383 6239
    Email
    michael.behnes@umm.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ibrahim Akin, Prof. Dr.
    Phone
    +49 621 383 5229
    Email
    ibrahim.akin@umm.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Behnes, Prof. Dr.
    Organizational Affiliation
    Universitätsmedizin Mannheim
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kambis Mashayekhi, PD Dr.
    Organizational Affiliation
    MEDICLIN Herzzentrum Lahr
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ibrahim Akin, Prof. Dr.
    Organizational Affiliation
    Universitätsmedizin Mannheim
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    CTO-PCI in Heart Failure Patients

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