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Heart FailureCRID-CRTNCT02525185

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

An observational study of Heart Failure and Cardiomyopathy, run by Oslo University Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiomyopathy
What is being tested?
Diagnostic interventions; PET, MRI, cardiac ultrasound.
How many people
200 participants
Where
2 sitesin 2 countries
Study dates
Sep 2015to Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Universitaire Ziekenhuizen Leuven

    Leuven

Other trials in Belgium

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

About this study

Official title: 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.

Being tested
Diagnostic interventions; PET, MRI, cardiac ultrasound.
Medical subject headings
Heart Failure, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reverse remodelling at 6 months follow-up

    Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

    Measured: 6 months

Secondary outcomes (7)

  1. Reverse remodelling at 12 months follow-up

    Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

    Measured: 12 months

  2. Quality of Life Changes

    Changes in quality of life measured by the Minnesota Living With Heart Failure Questionnaire

    Measured: 6 months

  3. New York Heart Association (NYHA) Class Changes

    Measured: 6 months

  4. Heart failure hospitalizations

    Measured: 12 months

  5. Death of any cause

    Measured: 5 years

  6. Heart transplantation

    Measured: 5 years

  7. Left atrial contractile synchrony

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion1 Jul 2018
  4. Study completionAug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02525185
Sponsor's protocol ID
2015/1022
Acronym
CRID-CRT
Status last verified
Oct 2023
First submitted
11 Aug 2015
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 32918449

  • 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.

    PubMed 39570213

  • 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.

    PubMed 36460211

  • 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.

    PubMed 31954643

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Cardiomyopathy, run by Oslo University Hospital at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reverse remodelling at 6 months follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02525185, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.

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