Evaluation of resynchronization therapy for heart failure (EARTH)

ISRCTN	ISRCTN42560370
DOI	https://doi.org/10.1186/ISRCTN42560370
ClinicalTrials.gov number	NCT00900549
Secondary identifying numbers	UCT-67914

Submission date: 09/09/2005
Registration date: 09/09/2005
Last edited: 19/02/2019

Recruitment status: No longer recruiting
Overall study status: Stopped
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bernard Thibault
Scientific

Montreal Heart Institute
5000 Belanger Street East
Montreal
H1T 1C8
Canada

Phone	+1 514 376 3330 ext. 3776
Email	earth-study.icm@icm-mhi.org

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Evaluation of resynchronization therapy for heart failure (EARTH)
Study acronym	EARTH
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2003
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	240
Key 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
Key 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
Date of first enrolment	01/11/2003
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

Canada

Study participating centre

Montreal Heart Institute

Montreal
H1T 1C8
Canada

Sponsor information

Montréal Heart Institute (Canada)
Research organisation

5000 est, rue Bélanger
Montréal
H1T 1C8
Canada

Phone	+1 514 376 3330
Email	earth-study.icm@icm-mhi.org
Website	http://www.icm-mhi.org/en/index.html
"ROR"	https://ror.org/03vs03g62

Funders

Funder type

Research organisation

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/02/2019: Clinicaltrials.gov stated that this trial was terminated by July 2011 due to lack of difference between groups.