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Cardiac Resynchronization TherapyRICARTNCT02528032

Revisit the Value of Imaging in Best Using CArdiac Resynchronization Therapy

A study testing Echographic evaluation of heart function in people with Cardiac Resynchronization Therapy, run by Rennes University Hospital at 1 site in France.

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

Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT restores contraction coordination between different regions of the left ventricle, which yields a significant improvement in LV systolic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Resynchronization Therapy
What is being tested?
Echographic evaluation of heart function
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFrance
Study dates
Aug 2015to Sep 2018
Phase
Interventional
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

Who may be able to join

  • Any patient with sinus rhythm sent to hospital for a cardiac resynchronization according to ESC criteria and implanted with a left ventricular pacing lead quadrupole

Who cannot join

  • Patients with an acoustic window is incompatible with the accurate echographic assessment of heart function
  • Patients with spontaneous one year prognosis is not dependent on his heart or another disease to the forefront (eg neoplasia)
  • Contra-indications to MRI (pacemaker or implantable defibrillator, intracranial ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body, Starr-Edwards heart valve prosthesis pre 6000, biomedical device type pump insulin or neurostimulator) or against -indications to iodinated contrast injection (severe renal impairment, allergy).
  • Patient not giving free and informed consent.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Pontchaillou

    Rennes, 35000

Other trials in France

About this study

Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT restores contraction coordination between different regions of the left ventricle, which yields a significant improvement in LV systolic function, symptoms, exercise tolerance and quality of life. In the longer term, treatment with resynchronization induces a reverse remodeling of the left ventricle and a decrease in mortality and morbidity (hospitalization for heart failure). Nevertheless, even if a majority of patients treated with CRT feel the benefit, some (up to 40% depending on the response criteria of CRT) do not experience significant improvement (nonresponders). Echocardiography and imaging have not so far demonstrated their added value to optimize delivery of CRT. Monocentric promising work on limited numbers of patients, however, were carried out. Meanwhile, equipment for delivering CRT evolves and new probes with four poles stimulation of the left ventricle are now used. The objective of this research is to validate new sequences of ultrasound processing estimating the CRT. These tools are based on usual echocardiographic examination of patients

Read the detailed description

Pilot study for testing tools pre and post-treatment images echocardiography but also MRI with a descriptive purpose and identification of the computed parameters should be secondarily test a large multicenter cohort . Patients in the study will be explored in RICART preimplantation as then in the manner used in current clinical routine. The use of data by cons will focus on the study of new tools ever compared in the same patients.

Data echocardiography (as with other techniques) are those used in clinical routine. Then, the data processing to be carried characterized the asynchrony posteriori, regardless of initial clinical data on a dedicated search software. Each quantitative parameter will be compared with others in order to predict the response to resynchronization. Response prediction of threshold values to the resynchronization can be obtained and compared to each of the tools. The value of relative and an addition to another may be tested.

The predictive value of the change (delta) of each parameter between the pre- and post-implantation to predict response to al resynchronization, will be evaluated.

Being tested
Echographic evaluation of heart function
Keywords
Left ventricular dysfunction, Other cardiac dysrhythmias
Medical subject headings
Ventricular Dysfunction, Left

What participants receive

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

  • Echographic evaluation of heart functionOther

    Echocardiographic data collection and analysis, not fully exploited at present

Study groups in NCT02528032
Study groupRoleWhat they receive
Echocardiographic evaluationOtherEchocardiographic evaluation of heart function with new processing tools
Receives: Other: Echographic evaluation of heart function

What is being measured

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

  1. Measuring the prognostic value of a package of new ultrasonic signal processing tools

    To evaluate the prognostic value of a package of new tools quantitatively measuring mechanical dyssynchrony prior to implantation of a resynchronization pacemaker in terms of favorable response at 6 months.

    Measured: pre-implantation

Secondary outcomes (4)

  1. Compare pre and post-implantation asynchrony characterisation

    pre and within three day post implantation mechanical asynchrony by package of new tools will be compared with the same characterization of biventricular pacemaker.

    Measured: pre-implantation, and within three day post implantation

  2. Characterization of the pre-implantation mechanical asynchrony by package of new tools

    The characterization of the pre-implantation mechanical asynchrony with the package of tested tools will be correlated with the results of:

    • Replacement fibrosis mark (taking gadolinium) and interstitial fibrosis (T1 mapping) [MRI]
    • Evaluation of the coronary venous system by chest CT

    Measured: pre-implantation

  3. Analysis and comparison of cardiac mechanical asynchrony characterization tools with other asynchronism criteria already describe

    cardiac mechanical asynchrony characterization tools will be analyzed and compared, associated with other asynchronism criteria already described defined by the reverse LV remodeling 6 months post-implantation (positive response regressions = ≥15% of tele-systolic volumes VG 6 months) to define the best or the best combination of predictive tools of the response to the CRT)

    Measured: at 6 month

  4. Prediction score

    definition of a prediction score of the answer to the CRT (echocardiographic and multi-modality)

    Measured: at 6 month

Timeline

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

  1. First posted19 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2018
  4. Study completionSep 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528032
Sponsor's protocol ID
35RC14-9767
Acronym
RICART
Status last verified
May 2023
First submitted
14 Aug 2015
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • Galli E, Le Rolle V, Smiseth OA, Duchenne J, Aalen JM, Larsen CK, Sade EA, Hubert A, Anilkumar S, Penicka M, Linde C, Leclercq C, Hernandez A, Voigt JU, Donal E. Importance of Systematic Right Ventricular Assessment in Cardiac Resynchronization Therapy Candidates: A Machine Learning Approach. J Am Soc Echocardiogr. 2021 May;34(5):494-502. doi: 10.1016/j.echo.2020.12.025. Epub 2021 Jan 7.

    PubMed 33422667

  • 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

  • Donal E, Hubert A, Le Rolle V, Leclercq C, Martins R, Mabo P, Galli E, Hernandez A. New Multiparametric Analysis of Cardiac Dyssynchrony: Machine Learning and Prediction of Response to CRT. JACC Cardiovasc Imaging. 2019 Sep;12(9):1887-1888. doi: 10.1016/j.jcmg.2019.03.009. Epub 2019 Apr 17. No abstract available.

    PubMed 31005538

  • Galli E, Hubert A, Le Rolle V, Hernandez A, Smiseth OA, Mabo P, Leclercq C, Donal E. Myocardial constructive work and cardiac mortality in resynchronization therapy candidates. Am Heart J. 2019 Jun;212:53-63. doi: 10.1016/j.ahj.2019.02.008. Epub 2019 Mar 4.

    PubMed 30951976

  • Donal E, Galli E, Cosyns B. Twenty years after starting cardiac resynchronization therapy, do we understand the electromechanical coupling? Eur Heart J Cardiovasc Imaging. 2019 Mar 1;20(3):257-259. doi: 10.1093/ehjci/jey152. No abstract available.

    PubMed 30371762

  • Galli E, Leclercq C, Hubert A, Bernard A, Smiseth OA, Mabo P, Samset E, Hernandez A, Donal E. Role of myocardial constructive work in the identification of responders to CRT. Eur Heart J Cardiovasc Imaging. 2018 Sep 1;19(9):1010-1018. doi: 10.1093/ehjci/jex191.

    PubMed 28954293

  • Galli E, Leclercq C, Fournet M, Hubert A, Bernard A, Smiseth OA, Mabo P, Samset E, Hernandez A, Donal E. Value of Myocardial Work Estimation in the Prediction of Response to Cardiac Resynchronization Therapy. J Am Soc Echocardiogr. 2018 Feb;31(2):220-230. doi: 10.1016/j.echo.2017.10.009. Epub 2017 Dec 13.

    PubMed 29246513

Questions about this trial

What is this clinical trial studying?

A study testing Echographic evaluation of heart function in people with Cardiac Resynchronization Therapy, run by Rennes University Hospital at 1 site in France.

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 1 inclusion and 4 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Measuring the prognostic value of a package of new ultrasonic signal processing tools (time frame: pre-implantation). 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 NCT02528032, which also lists 7 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 24 May 2023.

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