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

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ClinicalTrials.gov Identifier: NCT02525185
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Rennes University Hospital
Karolinska University Hospital
Onze Lieve Vrouwziekenhuis Aalst
Information provided by (Responsible Party):
Otto Armin Smiseth, Oslo University Hospital

Brief Summary:
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. Since segments which shorten in systole perform positive work, whereas segments which lengthen do negative work, the investigators will calculate wasted work as negative work in percentage of positive work. The main purpose of the study is to determine if wasted work can predict response to CRT.

Condition or disease Intervention/treatment
Heart Failure Cardiomyopathy Other: Diagnostic interventions; PET, MRI, cardiac ultrasound.

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contractile Reserve in Dyssynchrony (CRID): A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy
Study Start Date : September 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : December 2018



Primary Outcome Measures :
  1. Percentage of Non-responders and Responders to CRT [ Time Frame: 6 months ]
    Measured by left ventricular end systolic volume reduction of at least 15% assessed by echocardiography


Secondary Outcome Measures :
  1. Percentage of Non-responders and Responders to CRT [ Time Frame: 12 months ]
    Measured by left ventricular (LV) end systolic volume reduction of at least 15% assessed by echocardiography

  2. 6 Minutes Walking Test Changes [ Time Frame: Baseline and 6 months ]
  3. Peak Oxygen Uptake Changes [ Time Frame: Baseline and 6 months ]
  4. Quality of Life Changes [ Time Frame: Baseline and 6 months ]
    Changes in quality of life measured by the Minnesota Living With Heart Failure Questionnaire

  5. Reverse LV Remodeling [ Time Frame: 6 months ]
    Reverse left ventricular remodeling measured as changes in left ventricular end-diastolic volume, end-systolic volume and ejection fraction by echocardiography

  6. Reverse LV Remodeling [ Time Frame: 12 months ]
    Reverse left ventricular remodeling measured as changes in left ventricular end-diastolic volume, end-systolic volume and ejection fraction by echocardiography

  7. New York Heart Association (NYHA) Class Changes [ Time Frame: Baseline and 6 months ]
  8. Hospital Admissions Caused by Heart Failure (HF) [ Time Frame: 12 months ]
  9. Death [ Time Frame: 12 months ]
    Death by HF, sudden cardiac death and death of any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who are indicated for CRT device according to European Society of Cardiology (ESC) guidelines (2013).
Criteria

Inclusion Criteria:

Subject is indicated for CRT device according to current European Society of Cardiology (ESC) guidelines (2013):

  • Before CRT is considered, the patient should receive guideline-directed optimal medical therapy for heart failure and LV function must be severely depressed (LVEF ≤35%). In addition the following criteria must be fulfilled:

    1. NYHA functional class II, III or ambulatory IV and in stable sinus rhythm last two weeks.
    2. ECG: Left Bundle Branch Block (LBBB) with QRS duration >120 ms and non-LBBB with QRS >150 ms.
  • Patient with conventional pacemaker in NYHA functional class III and ambulatory IV if high percentage of ventricular pacing.
  • Subject is willing to sign informed consent form and is 18 years or older.

Exclusion Criteria:

  • Right bundle branch block.
  • Permanent atrial fibrillation
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525185


Locations
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Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Universitaire Ziekenhuizen Leuven
Rennes University Hospital
Karolinska University Hospital
Onze Lieve Vrouwziekenhuis Aalst
Investigators
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Principal Investigator: Otto A Smiseth, MD PhD Oslo University Hospital
Principal Investigator: Jens-Uwe Voigt, MD PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: Otto Armin Smiseth, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02525185     History of Changes
Other Study ID Numbers: 2015/1022
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases