To date, no dedicated prospective, randomized, blinded trials have been performed to assess the benefit of CRT in patients with NICD. It is difficult to hypothesize whether CRT implantation may be beneficial in patients with NICD. The objective of…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite of 2 clinical endpoints (12 months all-cause deaths and percentage of
hospitalizations for HF at 12 months) combined using an average z-score.
Secondary outcome
Evaluation of efficacy, analysis of:
- 12- month deaths (HF, cardiovascular and all causes deaths),
- Quality-of-life questionnaires at 6 and 12 months:
o Minnesota Living With Heart Failure Questionnaire: MLWHFQ): improvement of at
least 20 points
- Functional capacity at 6 and 12 months:
o NYHA classification reduction >= 1 class,
o 6-minute walk test improvement of at least 10 % in distance,
o Peak oxygen consumption increased by 1.0 ml/kg/min13,
- Percentage of hospitalizations for HF, for cardiovascular reasons and for all
causes at 6 and 12 months,
- Decrease >15% in end-diastolic and/or end-systolic volumes of the left
ventricle at 6 and 12 months.
Background summary
Several randomized control trials have found1-6, cardiac resynchronization
therapy (CRT) to be beneficial in heart failure patients with reduced left
ventricular ejection fraction (HFREF) and prolonged QRS duration. The concept
of resynchronization is challenged by the observation that for patients with
similar QRS duration, the ones with left bundle branch block (LBBB) respond
significantly better than the ones with nonspecific intraventricular conduction
delay (NICD). Its definition9, 'wide QRS without the appearance of left or
right bundle block', corresponds to a definition by default. Nonspecific
intraventricular conduction delay (NICD) is observed in a variety of
pathologies and results obtained following CRT are evaluated on limited sample
sizes, without dedicated randomized studies. Moreover, the observed results can
at times be conflicting. The latest international guidelines tend to restrict
the indications in this setting and the question arises as to whether to
continue to implant heart failure patients with NICD.
The proposed study will be the first randomized prospective assessment of
benefit of CRT in HFREF with NICD.
Study objective
To date, no dedicated prospective, randomized, blinded trials have been
performed to assess the benefit of CRT in patients with NICD. It is difficult
to hypothesize whether CRT implantation may be beneficial in patients with
NICD. The objective of the present study is to assess the clinical
effectiveness of cardiac resynchronization therapy in HF with reduced ejection
fraction patients with NICD on 12-month HF status.
Study design
This is a prospective, controlled, two-parallel arm, randomized, double-blind
design and multicentric clinical trial comparing a CRT-D or CRT-P ON group (DDD
or VVI biventricular mode, clinicians will define for each patients the best
atrioventricular delays) vs. CRT-D or CRT-P OFF group (back-up stimulation
mode: VVI 40 bpm) in HF with reduced ejection fraction patients with NICD. The
programming of randomization will be introduced after the completion of
baseline*s assessment (clinical examination, biological sample, trans-thoracic
echocardiography, 6 min walking test, QOL and VO2). Patients who had theses
exams performed before implantation, will be randomized directly after and
before the discharge. However, patient who didn*t received exams before
implantation, will be seen within two weeks from the implantation, for the
realization of these tests. In this situation, after implantation, the device
is set on OFF and will be activated according to the arm of randomization after
baseline assessment. Remote monitoring will be activated systematically in all
included patients before discharge.
Intervention
A pacemaker or defibrillator associated with a CRT system will be implanted
according to the standard care procedures. The decision to implant a pacemaker
or a defibrillator associated with CRT system will be taken by interventional
cardiologist according to guidelines, age of the patient, etiology of the
cardiopathy and habits.
The group of 200 patients will be randomly divided into 2 groups: (1) the
CRT-ON group: activated CRT system or (2) the CRT-OFF group: inactivated CRT
system.
Study burden and risks
The expected benefit of the present study might be an improvement in NYHA
class, quality of Life and decrease of HF hospitalizations and mortality.
Patients included in the present are not exposed to specific risk since devices
used in CRT implantation are currently used in standard care.
Montalembert 58
Clermont-Ferrand Cedex 1 63003
FR
Montalembert 58
Clermont-Ferrand Cedex 1 63003
FR
Listed location countries
Age
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):
o Not broad notched or slurred R wave in leads I, aVL, V5 and V6;
o Presence of a Q wave in leads I, V5, V6;
o 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
- Inability to understand nor decline the study,
- Impaired mobility,
- Unable to fill out questionnaire independently,
- Patients with permanent atrial fibrillation,
- Pregnant women,
- Dependant adult,
- Patients minor,
- Life expectancy < 1 year due to other causes than HF.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 02454439 |
| CCMO | NL65130.068.18 |