Evaluation of Resynchronization Therapy for Heart Failure (EARTH)

NCT00901212 | Completed Phase 4 DMC

• 2 other identifiers: UCT-67914 (Greater Earth)42560370
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 11

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).

Conditions

Heart Failure

Keywords

Heart Failure; resynchronisation; ICD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical, electrical, echocardiographic, MUGA scan endpoints, Neuro-hormones

  one year

Study Arms (2)

LV Pacing

ACTIVE COMPARATOR

left univentricular pacing

Device: Device programming

BV Pacing

ACTIVE COMPARATOR

biventricular pacing

Device: Device programming

Interventions

Device programming DEVICE

6-month period

BV Pacing; LV Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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?
• 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)?
• Did the patient have myocardial infarction or cardiac surgery in the 6 weeks preceding the pre-implant visit?
• Does the patient have a moderate or severe cardiac valve stenosis?
• 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)?
• Does the patient have severe coexisting illnesses making survival \> 6 months unlikely?
• Is the patient pregnant and/or nursing?
• Is the patient unable or unwilling to consent or to comply with follow-up requirements?
• Is the patient participating in another clinical study potentially interfering with the present trial?
• Does the patient have a resynchronization system in place?

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Abbott Medical Devices: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (11)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

St-Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook & Women's Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

St-Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

CHUS-Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

CHUM-Hôpital Hotel-Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Sacre-Coeur Hospital

Montreal, Quebec, H4J 1C5, Canada

Location

Institut Univ de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (3)

• Legris V, Thibault B, Dupuis J, White M, Asgar AW, Fortier A, Pitre C, Bouabdallaoui N, Henri C, O'Meara E, Ducharme A; EARTH Investigators. Right ventricular function and its coupling to pulmonary circulation predicts exercise tolerance in systolic heart failure. ESC Heart Fail. 2022 Feb;9(1):450-464. doi: 10.1002/ehf2.13726. Epub 2021 Dec 24.

  PMID: 34953062 DERIVED

• Thibault B, Ducharme A, Harel F, White M, O'Meara E, Guertin MC, Lavoie J, Frasure-Smith N, Dubuc M, Guerra P, Macle L, Rivard L, Roy D, Talajic M, Khairy P; Evaluation of Resynchronization Therapy for Heart Failure (GREATER-EARTH) Investigators. Left ventricular versus simultaneous biventricular pacing in patients with heart failure and a QRS complex >/=120 milliseconds. Circulation. 2011 Dec 20;124(25):2874-81. doi: 10.1161/CIRCULATIONAHA.111.032904. Epub 2011 Nov 21.

  PMID: 22104549 DERIVED

• Thibault B, Harel F, Ducharme A, White M, Frasure-Smith N, Roy D, Philippon F, Dorian P, Talajic M, Dubuc M, Gagne P, Guerra PG, Macle L, Rivard L, Khairy P. Evaluation of resynchronization therapy for heart failure in patients with a QRS duration greater than 120 ms (GREATER-EARTH) trial: rationale, design, and baseline characteristics. Can J Cardiol. 2011 Nov-Dec;27(6):779-86. doi: 10.1016/j.cjca.2011.03.010. Epub 2011 Jul 24.

  PMID: 21791363 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bernard MD, Thibault

  Montreal Heart Institute Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: October 1, 2003
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

CA (11)