Evaluation of Resynchronization Therapy for Heart Failure (EARTH) (EARTH)

May 6, 2012 updated by: Bernard Thibault, Montreal Heart Institute

Evaluation fo Resynchronization Therapy for Heart Failure (EARTH)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St-Paul's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St-Michael's Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook & Women's Hospital
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Fleurimont
      • Montreal, Quebec, Canada, H1T1C8
        • Montreal Heart Institute
      • Montréal, Quebec, Canada, H2W 1T8
        • CHUM-Hôpital Hotel-Dieu
      • Montréal, Quebec, Canada, H4J 1C5
        • Sacre-Coeur Hospital
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Univ de Cardiologie et de Pneumologie de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (for Greater and Lesser EARTH):

Patient must answer "yes"

  1. Does the patient require an ICD or an ICD replacement?
  2. Does the patient have a documented LVEF less than or equal to 35% measured in the previous 6 months (without major concomitant clinical event)?
  3. Does the patient have a QRS duration < 120 ms?
  4. Is the patient in sinus rhythm?
  5. Was the six-minute walk test distance less than 400 meters and limited by heart failure symptoms?

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LV Pacing
left univentricular pacing
Device: Device programming
6-month period
Active Comparator: BV Pacing
biventricular pacing
Device: Device programming
6-month period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical, electrical, echocardiographic, MUGA scan endpoints, Neuro-hormones
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

Canadian Institutes of Health Research (CIHR)
Abbott Medical Devices

Investigators

  • Study Chair: Bernard MD, Thibault, Montreal Heart Institute Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCT-67914 (Greater Earth)
  • 42560370

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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