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Completed

NCT Number: NCT02525185

Contractile Reserve in Dyssynchrony: A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy

Cardiac resynchronisation therapy (CRT) has been documented to be a powerful treatment in patients with severe congestive heart failure. However, 30-40% of patients receiving a CRT are non-responders. In this study the investigators will use a previously validated method to estimate myocardial segment work non-invasively by speckle-tracking echocardiography and blood pressure. Furthermore, cardiac magnetic resonance imaging (CMR) with late gadolinium enhancement (LGE) will be performed in feasible subjects. The main purpose of the study is to determine if myocardial work by echocardiography in combination with viability assessment by LGE-CMR can predict response to CRT.

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Key information

Conditions

Heart Failure Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is indicated for CRT device according to European Society of Cardiology (ESC) guidelines from 2013.
  • Subject is willing to sign informed consent form and is 18 years or older.

Exclusion criteria

  • Right bundle branch block.
  • Recent myocardial infarction, within 40 days prior to enrollment.
  • Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
  • Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
  • Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
  • Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period).
  • Complex and uncorrected congenital heart disease.
  • Breastfeeding women or women of child bearing potential.
  • Enrolled in one or more concurrent studies that would confound the results of this study.
  • Impossible to obtain LV volumes by echocardiography

Treatment and study plan

Diagnostic interventions; PET, MRI, cardiac ultrasound.

Other

Primary outcomes

  1. Reverse remodelling at 6 months follow-up

    Time frame: 6 months

    Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

Secondary outcomes

  1. Reverse remodelling at 12 months follow-up

    Time frame: 12 months

    Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

  2. Quality of Life Changes

    Time frame: 6 months

    Changes in quality of life measured by the Minnesota Living With Heart Failure Questionnaire

  3. New York Heart Association (NYHA) Class Changes

    Time frame: 6 months

  4. Heart failure hospitalizations

    Time frame: 12 months

  5. Death of any cause

    Time frame: 5 years

  6. Heart transplantation

    Time frame: 5 years

  7. Left atrial contractile synchrony

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Karolinska University Hospital
  • Onze Lieve Vrouwziekenhuis Aalst
  • Rennes University Hospital
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

Contractile Reserve in Dyssynchrony (CRID): A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy

Acronym: CRID-CRT

Important dates

Study start
2015
Primary completion
2018
Study completion
2023
First posted
Aug 17, 2015
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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