Clinical trial NCT00900549: Evaluation of Resynchronization Therapy for Heart Failure
Official title: EvaluAtion of Resynchronization Therapy for Heart Failure (EARTH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart failure
Cardiac resynchronization therapy
ICD
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-05-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart failure is a major health problem in Canada. Recent advances in medical and device therapy have helped to reduce the morbidity and mortality of patients with this problem. Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown to be effective to improve functional class, quality of life and exercise tolerance of the patients with the most severe symptoms of heart failure and a prolonged duration of the QRS on the 12-lead Electrocardiography (ECG).

Detailed description: Resynchronization of the failing ventricle is currently achieved by pacing the left and right ventricles simultaneously with specialized electrodes and a cardiac stimulator. However, controversy persists concerning the optimal configuration for cardiac pacing in these patients. Right ventricular pacing alone has been shown to be deleterious in some patient populations. The benefits of biventricular pacing in heart failure patients may be due primarily to left ventricular stimulation and may, in some patients, be decreased by the presence of simultaneous RV stimulation. Preliminary data from our own animal work suggest that in the majority of cases, LV stimulation alone is better than RV stimulation, and that BiV stimulation represents an intermediary situation between LV and RV stimulation.

Eligibility criteria: Inclusion Criteria:

* The patients are eligible if they undergo an ICD implantation or replacement
* They have a documented LVEF ≤ 35% measured in the previous 6 months (without major clinical subsequent event, such as heart surgery, since the LVEF measurement)
* If measured by echocardiography, the LV end-diastolic diameter must be ≥ 60 mm
* The duration of the QRS is \< 120 ms
* They are in sinus rhythm
* They cannot walk more than 400 meters during the screening 6-minute walk test (the patients must be limited by heart failure symptoms)

Exclusion Criteria:

* Patients with an indication for permanent ventricular pacing or with chronotropic insufficiency defined as follow:

  * Any condition where the treating physician believes it would not be acceptable for the patient to have his device NOT programmed with the SENSOR at ON for the duration of the study
  * Second or third degree AV block, either persistent or intermittent
  * Patients with a pacemaker or an ICD who are paced in the ventricular chamber more than 5% of the time
* Patients with LV dysfunction associated with a reversible cause such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)
* Patients who had a myocardial infarction within the past 6 weeks\* defined by 2 of the 3 following conditions:

  * Prolonged chest pain
  * ECG changes suggesting of AMI
  * Cardiac enzymes elevation more than twice the local upper limit of normal)
* Patients who had cardiac surgery within the past 6 weeks\*
* Patients with moderate or severe cardiac valve stenosis (aortic, mitral, pulmonary or tricuspid)
* Patients with an inability or a limitation to walk for reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthrosis)
* Patients with severe coexisting illnesses making survival \> 6 months unlikely
* Patients who are pregnant and/or nursing.
* Patients with inability or unwillingness to consent or comply with follow-up requirements
* Patients participating in another study

The 6-week period is calculated prior to the beginning of the baseline evaluation and not the implant procedure itself. This difference comes from the fact that the protocol includes a delay of 2 to 8 weeks between the implant procedure and the actual beginning of the patient's evaluation.

Primary outcomes:
measure: Total exercise duration at a constant submaximal load (defined as 75% of peak exercise during the baseline metabolic evaluation); study is powered to detect a min difference of 300 sec (+25% from baseline) in the primary endpoint between the 2 treatments
timeFrame: one year
Secondary outcomes:
measure: Clinical & electrical endpoints and echocardiographic & nuclear medicine evaluation of LV function. Dyssynchrony evaluation will help advancing the understanding of the physiopathology of heart failure and response to resynchronization therapy.
timeFrame: one year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's Hospital
state: Ontario
city: Toronto
country: Canada
facility: St-Michael's Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: CHUS-Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute Research Center
state: Quebec
city: Montréal
country: Canada
facility: CHUM-Hôpital Hotel-Dieu
state: Quebec
city: Montréal
country: Canada
facility: Sacre-Coeur Hospital
state: Quebec
city: Québec
country: Canada
facility: Institut Univ de Cardiologie et de Pneumologie de Québec
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Bernard Thibault, MD
role: STUDY_CHAIR
References:
citation: Thibault B, Harel F, Ducharme A, White M, Ellenbogen KA, Frasure-Smith N, Roy D, Philippon F, Dorian P, Talajic M, Dubuc M, Guerra PG, Macle L, Rivard L, Andrade J, Khairy P; LESSER-EARTH Investigators. Cardiac resynchronization therapy in patients with heart failure and a QRS complex <120 milliseconds: the Evaluation of Resynchronization Therapy for Heart Failure (LESSER-EARTH) trial. Circulation. 2013 Feb 26;127(8):873-81. doi: 10.1161/CIRCULATIONAHA.112.001239. Epub 2013 Feb 6.