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Assessment of Cardiac Resynchronization Therapy in Patients With Wide QRS and Non-specific Intraventricular Conduction Delay: a Randomized Trial

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ClinicalTrials.gov Identifier: NCT02454439
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : May 27, 2015
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF patients with NICD and reduced ejection fraction on 12-month HF status.

In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with reduced ejection fraction patients with non specific intraventricular conduction delay (NICD) has never been confirmed even if it is recommended.

At the moment, no dedicated study has already been performed to assess the benefit of CRT in patients with NICD. Results from CRT therapy are contradictory in this patient group and have only been obtained from subgroup analysis. Some of them don't show clinical benefit but others show a benefit in term of an end-diastolic and/or end-systolic left ventricular volume (decrease of the size and the volumes of left ventricule).

The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration (≥120 ms) for the indication of CRT implantation, without any consideration for the type of conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines, consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in addition to QRS duration (>150 ms). Indications for resynchronization have been restricted since indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only in NYHA III and ambulatory IV; level of evidence A). The same modifications have been applied between 2011 and 2013 in the European guidelines. None is known about patients with NICD and QRS > 130 ms.


Condition or disease Intervention/treatment Phase
Heart Failure Other: CRT implantation Phase 4

Detailed Description:

This is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD.

Patients will be included in twelve French centers (Clermont-Ferrand University Hospital, Côte Basque Hospital, Bordeaux University Hospital, Saint-Augustin Clinic, Limoges University Hospital, Grenoble University Hospital, Nantes University Hospital, Nantes New Clinic, Rennes University Hospital, Saint-Etienne University Hospital, Tours University Hospital, Toulouse University Hospital).

  1. At baseline a preimplantation evaluation is performed: clinical examination, ECG, six minute walk test, biology analysis, quality of life assessment, echocardiography, peak oxygen consumption.
  2. At 6 months, evaluation of efficacy which is the secondary assessment criteria:

    • Quality of life: Minnesota Living With Heart Failure Questionnary: MLWHFQ) : improvement of at least 20 points
    • Functionnal capacity :

    NYHA classification reduction ≥ 1 class, 6-minute walk test improvement of at least 10 % in distance, Peak oxygen consumption increased by 1.0 ml/kg/minNYHA response to CRT is the primary endpoint. It is a composite primary endpoint, including modification of: Quality of Life Score (MINNESOTA scale), NYHA functional status , 6-minute walk test and volume of the left ventricle.

    - Percentage of hospitalizations for HF, for cardiovascular reasons and for all causes Decrease >15% in end-diastolic and/or end-systolic volumes of the left ventricle.

  3. At 12 months, comparison of the proportion of improved, unchanged and worsend patients (Packer Score) in both group which is the primary endpoint and new evaluation of the CRT efficacy (same as 6 months)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Assessment of Cardiac Resynchronization Therapy in Patients With Wide QRS and Non-specific Intraventricular Conduction Delay: a Randomized Trial
Study Start Date : May 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CRT-D or CRT-P ON
This is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD.
Other: CRT implantation
CRT-D or CRT-P OFF
This is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD.
Other: CRT implantation



Primary Outcome Measures :
  1. proportion of improved, unchanged and worsened patients in both groups. [ Time Frame: at 12 months ]

    According to composite Packer classification:

    • Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) of a prespecified magnitude but did not experience any major adverse clinical events during the course of the trial.
    • Patients are considered worse if they experienced a major clinical event during the planned duration of double-blind treatment or reported worsening of their NYHA class or global assessment at the final visit.

    Patients are considered unchanged if they are neither improved nor worse.



Secondary Outcome Measures :
  1. Evaluation of efficacy, analysis of 12- month deaths [ Time Frame: at 6 and 12 months ]
    HF, cardiovascular and all causes deaths

  2. Evaluation of efficacy, analysis of - Quality-of-life questionnaires [ Time Frame: at 6 and 12 months ]
    Minnesota Living With Heart Failure Questionnaire: MLWHFQ): improvement of at least 20 points

  3. Evaluation of efficacy, analysis of Functional capacity [ Time Frame: at 6 and 12 months ]
    NYHA classification reduction ≥ 1 class, 6-minute walk test improvement of at least 10 % in distance, Peak oxygen consumption increased by 1.0 ml/kg/min

  4. Evaluation of efficacy, analysis of Percentage of hospitalizations for HF [ Time Frame: at 6 and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years' old
  • NYHA class II to IV ambulatory
  • QRS duration > 130 ms
  • Patients with sinus rhythm
  • LVEF < 35%
  • QRS morphology: NICD according to the AHA/ACCF/HRS Recommendations (non-LBBB and non-RBBB):
  • Not broad notched or slurred R wave in leads I, aVL, V5 and V6;
  • Presence of a Q wave in leads I, V5, V6;
  • No rsr', rsR' or rSR' pattern in leads V1 or V2.
  • Life expectancy expected to exceed one year with a good functional status
  • Optimal pharmacological therapy of heart failure according to clinician

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454439


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Romain ESCHALIER         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Boston Scientific Corporation
Investigators
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Principal Investigator: Romain ESCHALIER University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02454439     History of Changes
Other Study ID Numbers: CHU-0233
2014-A01848-39 ( Registry Identifier: 2014-A01848-39 )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by University Hospital, Clermont-Ferrand:
Heart Failure with reduced ejection fraction (<35%)
Cardiac Resynchronisation Therapy
Non specific intraventricular conduction
Efficacy
Life expectancy expected to exceed one year with a good functional status
QRS morphology : NICD according to the AHA/ACCF/HRS Recommendations (non-LBBB and non-RBBB):
QRS duration > 130 ms

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases