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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02525185
Acronym
CRID-CRT
Enrollment
200
Registered
2015-08-17
Start date
2015-09-30
Completion date
2023-08-31
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Heart Failure

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.

Interventions

OTHERDiagnostic interventions; PET, MRI, cardiac ultrasound.

Sponsors

Oslo University Hospital
Lead SponsorOTHER
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
Rennes University Hospital
CollaboratorOTHER
Karolinska University Hospital
CollaboratorOTHER
Onze Lieve Vrouwziekenhuis Aalst
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reverse remodelling at 6 months follow-up6 monthsMeasured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

Secondary

MeasureTime frameDescription
New York Heart Association (NYHA) Class Changes6 months
Heart failure hospitalizations12 months
Death of any cause5 years
Quality of Life Changes6 monthsChanges in quality of life measured by the Minnesota Living With Heart Failure Questionnaire
Left atrial contractile synchrony2 years
Reverse remodelling at 12 months follow-up12 monthsMeasured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography
Heart transplantation5 years

Countries

Belgium, Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026