Evaluation of Resynchronization Therapy for Heart Failure (EARTH)

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Device: Device programming

• Registration Number: NCT00901212
• Lead Sponsor: Montreal Heart Institute

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-06
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Patient must have answered "NO" to all of the exclusion criteria

1. Does the patient have:

   • Indication for permanent ventricular pacing?
   • Chronotropic insufficiency?
   • Second or third degree AV block, either persistent or intermittent?
   • A pacemaker or an ICD which is paced in ventricular chamber more than 5% of the time?

2. Does the patient have a reversible cause of LV dysfunction such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)?

3. Did the patient have myocardial infarction or cardiac surgery in the 6 weeks preceding the pre-implant visit?

4. Does the patient have a moderate or severe cardiac valve stenosis?

5. Is the patient's capacity to walk is limited by reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthritis)?

6. Does the patient have severe coexisting illnesses making survival > 6 months unlikely?

7. Is the patient pregnant and/or nursing?

8. Is the patient unable or unwilling to consent or to comply with follow-up requirements?

9. Is the patient participating in another clinical study potentially interfering with the present trial?

10. Does the patient have a resynchronization system in place?

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LV Pacing	Device programming	left univentricular pacing
BV Pacing	Device programming	biventricular pacing

Primary Outcome Measures

Name	Time	Method
The primary endpoint is total exercise duration at a constant submaximal load (ETT submaximal load is defined as 75% of peak exercise during the baseline metabolic evaluation)	one year

Secondary Outcome Measures

Name	Time	Method
Clinical, electrical, echocardiographic, MUGA scan endpoints, Neuro-hormones	one year

Trial Locations

Locations (11)

CHUM-Hôpital Hotel-Dieu; 🇨🇦 Montréal, Quebec, Canada

CHUS-Fleurimont; 🇨🇦 Fleurimont, Quebec, Canada

Sacre-Coeur Hospital; 🇨🇦 Montréal, Quebec, Canada

Institut Univ de Cardiologie et de Pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada

Sunnybrook & Women's Hospital; 🇨🇦 Toronto, Ontario, Canada

St-Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

St-Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada