Condition category
Circulatory System
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
05/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bernard Thibault

ORCID ID

Contact details

Montreal Heart Institute
5000 Belanger Street East
Montreal
H1T 1C8
Canada
+1 514 376 3330 ext. 3776
earth-study.icm@icm-mhi.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00900549

Protocol/serial number

UCT-67914

Study information

Scientific title

Acronym

EARTH

Study hypothesis

The primary hypothesis of the LESSER-EARTH is that heart failure patients with an indication for an implantable cardioverter defibrillator (ICD) without a prolonged QRS duration will benefit clinically from resynchronization therapy.

The primary hypothesis of the GREATER-EARTH is that heart failure patients with an indication for an ICD and for cardiac resynchronisation therapy (CRT) will benefit better clinically with left ventricular (LV)-based CRT than with biventricular (BiV)-based CRT.

As of 01/06/2009 and 05/06/2009 this record was updated. All updates can be found under the relevant field with the above update dates. At this time, the trial dates were updated; the initial trial dates at the time of registration were:
Initial anticipated start date: 01/01/2005
Initial anticipated end date: 31/12/2005

Ethics approval

Local ethics committee (Comité d'éthique de la recherche et du développement des nouvelles technologies de l'Institut de Cardiologie de Montréal) approved on the 11th November 2003.

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Heart failure

Intervention

1. Insertion of the resynchronization pacing system
2. Control tests to ensure condition is stable and device functioning properly
3a. Lesser-Earth: patients randomized to resynchronization on versus off. 12-month follow-up.
3b. Greater-Earth: patients randomized to LV resynchronization verus BiV resynchronization. Cross-over 6 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total exercise duration at constant sub-maximal load (defined as 75% of peak exercise during the baseline metabolic evaluation).

Secondary outcome measures

1. Clinical endpoints (Quality of Life [QoL], New York Heart Association [NYHA])
2. Electrical endpoints (ECG)
3. Echocardiographic endpoints (LVEF and volumes)
4. MUGA scan endpoints (LVEF and synchrony index)
5. Neuro-hormones (brain natriuretic peptide [BNP], atrial natriuretic peptide [ANP])

Overall trial start date

01/11/2003

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Correct and updated information as of 05/06/2009:
Patient must answer "yes" to the following questions:
1. Does the patient require an ICD or an ICD replacement?
2. Does the patient have a documented left ventricular ejection fraction (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 of less than 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?

Initial (incorrect) information at time of registration:
1. Diagnosis of asthma verified by primary care MD.
2. Aged greater than or equal to 18 years old, either sex
3. Asthma managed by primary care MD and receiving asthma drug therapy from primary care MD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

Amended as of 05/06/2009:
Point one of the below exclusion criteria has been amended as follows:
1. Indication for permanent pacing or with chronotropic insufficiency defined as follows:
1.1. 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
1.2. Second or third degree AV block, either persistent or intermittent block
1.3. Patients with a pacemaker or an ICD who are paced in either chamber (A or V) more than 5% of the time

Initial information at time of registration:
1. Indication for permanent pacing or with chronotropic insufficiency defined as follows:
1.1. Severe sinus bradycardia (resting heart rate less than 50/min)
1.2. Chronotropic insufficiency, defined as a heart rate during the screening 6-minute walk test that does not increase by more than 10 beats/minute compared to the resting rate
1.3. First degree AV block with a PR interval greater than 250 ms, Second or third degree AV block, either persistent or intermittent
1.4. Patients with a pacemaker or an ICD who are paced in either chamber (A or V) more than 5% of theme
2. LV dysfunction associated with a reversible cause such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)
3. Myocardial infarction within the past 6 weeks (defined by two of the three following conditions: prolonged chest pain, electrocardiogram (ECG) changes suggesting of acute myocardial infarction (AMI) or cardiac enzymes elevation more than twice the local upper limit of normal)
4. Cardiac surgery within the past 6 weeks
5. Coronary angioplasty within the past 6 months
6. Moderate or severe cardiac valve stenosis
7. Inability or a limitation to walk for reasons other than heart failure symptoms (e.g. angina, intermittent claudication, severe lung condition or arthrosis)
8. Severe coexisting illnesses making survival greater than 6 months unlikely
9. Pregnancy and/or nursing
10. Inability or unwillingness to consent or comply with follow-up requirements
11. Participation in another study

Recruitment start date

01/11/2003

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Canada

Trial participating centre

Montreal Heart Institute
Montreal
H1T 1C8
Canada

Sponsor information

Organisation

Montréal Heart Institute (Canada)

Sponsor details

5000 est
rue Bélanger
Montréal
H1T 1C8
Canada
+1 514 376 3330
earth-study.icm@icm-mhi.org

Sponsor type

Research organisation

Website

http://www.icm-mhi.org/en/index.html

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-67914)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

St. Jude Medical Canada Inc. (Mississauga, Ont) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes