CRID-CRT: Contractile Reserve in Dyssynchrony: A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy
Study Details
Study Description
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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Reverse remodelling at 6 months follow-up [6 months]
Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography
Secondary Outcome Measures
- Reverse remodelling at 12 months follow-up [12 months]
Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography
- Quality of Life Changes [6 months]
Changes in quality of life measured by the Minnesota Living With Heart Failure Questionnaire
- New York Heart Association (NYHA) Class Changes [6 months]
- Heart failure hospitalizations [12 months]
- Death of any cause [5 years]
- Heart transplantation [5 years]
- Left atrial contractile synchrony [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is indicated for CRT device according to European Society of Cardiology (ESC) guidelines from 2013.
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Subject is willing to sign informed consent form and is 18 years or older.
Exclusion Criteria:
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Right bundle branch block.
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Recent myocardial infarction, within 40 days prior to enrollment.
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Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
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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
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Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
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Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period).
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Complex and uncorrected congenital heart disease.
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Breastfeeding women or women of child bearing potential.
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Enrolled in one or more concurrent studies that would confound the results of this study.
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Impossible to obtain LV volumes by echocardiography
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitaire Ziekenhuizen Leuven | Leuven | Belgium | ||
| 2 | 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
- Principal Investigator: Otto A Smiseth, MD PhD, Oslo University Hospital
- Principal Investigator: Jens-Uwe Voigt, MD PhD, Universitaire Ziekenhuizen Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015/1022