NCT02525185

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

August 11, 2015

Last Update Submit

October 31, 2023

Conditions

Heart FailureCardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Reverse remodelling at 12 months follow-up

    12 months

  • Quality of Life Changes

    6 months

  • New York Heart Association (NYHA) Class Changes

    6 months

  • Heart failure hospitalizations

    12 months

  • Death of any cause

    5 years

  • +2 more secondary outcomes

Interventions

Diagnostic interventions; PET, MRI, cardiac ultrasound.OTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects who are indicated for CRT device according to European Society of Cardiology (ESC) guidelines (2013).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

Oslo University Hospital

Oslo, Norway

Location

Related Publications (4)

  • 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.

    PMID: 32918449RESULT

  • Hammersboen LR, Stugaard M, Puvrez A, Larsen CK, Remme EW, Kongsgard E, Duchenne J, Galli E, Khan FH, Sletten OJ, Penicka M, Donal E, Voigt JU, Smiseth OA, Aalen JM. Mechanism and Impact of Left Atrial Dyssynchrony on Long-Term Clinical Outcome During Cardiac Resynchronization Therapy. JACC Cardiovasc Imaging. 2025 Apr;18(4):421-432. doi: 10.1016/j.jcmg.2024.09.008. Epub 2024 Nov 20.

    PMID: 39570213DERIVED

  • Larsen CK, Galli E, Duchenne J, Aalen JM, Stokke C, Fjeld JG, Degtiarova G, Claus P, Gheysens O, Saberniak J, Sirnes PA, Lyseggen E, Bogaert J, Kongsgaard E, Penicka M, Voigt JU, Donal E, Hopp E, Smiseth OA. Scar imaging in the dyssynchronous left ventricle: Accuracy of myocardial metabolism by positron emission tomography and function by echocardiographic strain. Int J Cardiol. 2023 Feb 1;372:122-129. doi: 10.1016/j.ijcard.2022.11.042. Epub 2022 Nov 29.

    PMID: 36460211DERIVED

  • 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.

    PMID: 31954643DERIVED

MeSH Terms

Conditions

Heart FailureCardiomyopathies

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Otto A Smiseth, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Jens-Uwe Voigt, MD PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 17, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2018

Study Completion

August 1, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

BE(1)NO(1)