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Coronary Artery DiseaseCTO-HFNCT05632653

CTO-PCI in Heart Failure Patients

A study testing CTO-PCI in people with Coronary Artery Disease and Chronic Total Occlusion, run by Universitätsmedizin Mannheim.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
CTO-PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
783 participants
Where
No sites listed yet
Study dates
Sep 2025to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Michael Behnes, Prof. Dr. contact

+49 621 383 6239

michael.behnes@umm.de

About this study

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

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.

Read the 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.

Being tested
CTO-PCI
Medical subject headings
Coronary Artery Disease, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTO-PCIProcedure or surgery

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

Study groups in NCT05632653
Study groupRoleWhat they receive
CTO-PCIExperimentalNot described
Receives: Procedure: CTO-PCI
non-CTO-PCINo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 3 years

Secondary outcomes (9)

  1. Canadian cardiovascular society (CCS) class

    angina pectoris

    Measured: up to 3 years

  2. All-cause mortality.

    Measured: up to 3 years

  3. Heart failure related rehospitalization.

    Measured: up to 3 years

  4. 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.

    Measured: up to 3 years

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

    Measured: up to 3 years

  6. assessment of quality of life

    Seattle angina questionnaire (SAQ) (0-100; 75-100 normal).

    Measured: up to 3 years

  7. cost effectivenes

    direct and indirect health care related costs

    Measured: up to 3 years

  8. Re-assessment of LVEF

    Measured: up to 3 years

  9. New York Heart association (NYHA) class

    dyspnea

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study startSep 2025 (estimated)
  3. Primary completionMar 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
783 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05632653
Sponsor's protocol ID
01012022-MA
Acronym
CTO-HF
Status last verified
Sep 2024
First submitted
27 Jan 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CTO-PCI in people with Coronary Artery Disease and Chronic Total Occlusion, run by Universitätsmedizin Mannheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Behnes, Prof. Dr. (+49 621 383 6239, michael.behnes@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause mortality or heart failure related rehospitalization. (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05632653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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