Clinical trial NCT02525185: Contractile Reserve in Dyssynchrony: A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy
Official title: Contractile Reserve in Dyssynchrony (CRID): A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiomyopathy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Rennes University Hospital
name: Karolinska University Hospital
name: Onze Lieve Vrouwziekenhuis Aalst
First posted: 2015-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are indicated for CRT device according to European Society of Cardiology (ESC) guidelines (2013).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reverse remodelling at 6 months follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Reverse remodelling at 12 months follow-up
timeFrame: 12 months
measure: Quality of Life Changes
timeFrame: 6 months
measure: New York Heart Association (NYHA) Class Changes
timeFrame: 6 months
measure: Heart failure hospitalizations
timeFrame: 12 months
measure: Death of any cause
timeFrame: 5 years
measure: Heart transplantation
timeFrame: 5 years
measure: Left atrial contractile synchrony
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Otto A Smiseth, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jens-Uwe Voigt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 resynchronization therapy: left ventricular work asymmetry by echocardiography and septal viability by cardiac magnetic resonance. Eur Heart J. 2020 Oct 14;41(39):3813-3823. doi: 10.1093/eurheartj/ehaa603.
citation: Storsten P, Aalen JM, Boe E, Remme EW, Gjesdal O, Larsen CK, Andersen OS, Eriksen M, Kongsgaard E, Duchenne J, Voigt JU, Smiseth OA, Skulstad H. Mechanical Effects on Right Ventricular Function From Left Bundle Branch Block and Cardiac Resynchronization Therapy. JACC Cardiovasc Imaging. 2020 Jul;13(7):1475-1484. doi: 10.1016/j.jcmg.2019.11.016. Epub 2020 Jan 15.