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

NCT02454439 | Unknown

• 2 other identifiers: CHU-02332014-A01848-39
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite of 2 clinical endpoints combined (12 months all-cause deaths and percentage of hospitalizations for HF at 12 months) combined using an average z-score.

  According to z-score

  at 12 months

Secondary Outcomes (6)

• Evaluation of efficacy, analysis of 12- month deaths

  at 6 and 12 months

• Evaluation of efficacy, analysis of - Quality-of-life questionnaires

  at 6 and 12 months

• Evaluation of efficacy, analysis of Functional capacity

  at 6 and 12 months

• Evaluation of efficacy, analysis of Percentage of hospitalizations for HF

  at 6 and 12 months

• Evaluation of efficacy, analysis of left ventricule volume by echocardiography transthoracic

  at 6 and 12 months

Study Arms (2)

CRT-D or CRT-P ON

EXPERIMENTAL

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

OTHER

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

Interventions

CRT implantation OTHER

CRT-D or CRT-P OFF; CRT-D or CRT-P ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Inability to understand nor decline the study,
• Impaired mobility,
• Unable to fill out questionnaire independently,
• Patients with permanent atrial fibrillation,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• Eschalier R, Ploux S, Pereira B, Clementy N, Da Costa A, Defaye P, Garrigue S, Gourraud JB, Gras D, Guy-Moyat B, Leclercq C, Mondoly P, Bordachar P. Assessment of cardiac resynchronisation therapy in patients with wide QRS and non-specific intraventricular conduction delay: rationale and design of the multicentre randomised NICD-CRT study. BMJ Open. 2016 Nov 11;6(11):e012383. doi: 10.1136/bmjopen-2016-012383.

  PMID: 27836874 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Romain ESCHALIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gérald GOUBY

CONTACT

04 73 75 49 62; ggouby@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 27, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: June 28, 2021

Record last verified: 2015-09

Locations

FR (1)