Evaluation of Resynchronization Therapy for Heart Failure

Heart Failure Clinical Trial

— EARTH  

Official title:

EvaluAtion of Resynchronization Therapy for Heart Failure (EARTH)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00900549
• Other study ID #: UCT67914 (Lesser Earth)
• Secondary ID: ISRCTN 42560370
• Status: Terminated
• Phase: Phase 4
• First received: May 12, 2009
• Last updated: July 20, 2011
• Start date: October 2003
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: July 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRT on
12 months
• CRT off
12-month

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	CHUS-Fleurimont	Fleurimont	Quebec
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences Center	Hamilton	Ontario
Canada	Montreal Heart Institute Research Center	Montreal	Quebec
Canada	CHUM-Hôpital Hotel-Dieu	Montréal	Quebec
Canada	Sacre-Coeur Hospital	Montréal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut Univ de Cardiologie et de Pneumologie de Québec	Québec	Quebec
Canada	St-Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook & Women's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Montreal Heart Institute	Canadian Institutes of Health Research (CIHR), St. Jude Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one year	No
Secondary	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.		one year	No