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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cardiomyopathy
• Intervention / Treatment: Other: Diagnostic interventions; PET, MRI, cardiac ultrasound.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Universitaire Ziekenhuizen Leuven
• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Karolinska University Hospital; Universitaire Ziekenhuizen KU Leuven; Rennes 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 KU Leuven

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimated): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 2015/1022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED