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

Heart Failure Clinical Trial

— CRID-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525185
• Other study ID #: 2015/1022
• Status: Completed
• Start date: September 2015
• Est. completion date: August 2023

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure

Intervention

Other:
• Diagnostic interventions; PET, MRI, cardiac ultrasound.

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Norway	Oslo University Hospital	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Karolinska University Hospital, Onze Lieve Vrouwziekenhuis Aalst, Rennes University Hospital, Universitaire Ziekenhuizen KU Leuven

Countries where clinical trial is conducted

Belgium,  Norway, 

References & Publications (1)

Aalen JM, Donal E, Larsen CK, Duchenne J, Lederlin M, Cvijic M, Hubert A, Voros G, Leclercq C, Bogaert J, Hopp E, Fjeld JG, Penicka M, Linde C, Aalen OO, Kongsgard E, Galli E, Voigt JU, Smiseth OA. Imaging predictors of response to cardiac resynchronizati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reverse remodelling at 6 months follow-up	Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography	6 months
Secondary	Reverse remodelling at 12 months follow-up	Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography	12 months
Secondary	Quality of Life Changes	Changes in quality of life measured by the Minnesota Living With Heart Failure Questionnaire	6 months
Secondary	New York Heart Association (NYHA) Class Changes		6 months
Secondary	Heart failure hospitalizations		12 months
Secondary	Death of any cause		5 years
Secondary	Heart transplantation		5 years
Secondary	Left atrial contractile synchrony		2 years