Evaluation of Resynchronization Therapy for Heart Failure

NCT00900549 | Terminated Phase 4 DMC

• 2 other identifiers: UCT67914 (Lesser Earth)ISRCTN 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; Cardiac resynchronization therapy; ICD

Outcome Measures

Primary Outcomes (1)

• Total exercise duration at a constant submaximal load (defined as 75% of peak exercise during the baseline metabolic evaluation); study is powered to detect a min difference of 300 sec (+25% from baseline) in the primary endpoint between the 2 treatments

  one year

Secondary Outcomes (1)

• Clinical & electrical endpoints and echocardiographic & nuclear medicine evaluation of LV function. Dyssynchrony evaluation will help advancing the understanding of the physiopathology of heart failure and response to resynchronization therapy.

  one year

Study Arms (2)

CRT

EXPERIMENTAL

Device: CRT on

No CRT

SHAM COMPARATOR

Device: CRT off

Interventions

CRT on DEVICE

12 months

CRT

CRT off DEVICE

12-month

No CRT

Eligibility Criteria

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

You may qualify if:

• The patients are eligible if they undergo an ICD implantation or replacement
• They have a documented LVEF ≤ 35% measured in the previous 6 months (without major clinical subsequent event, such as heart surgery, since the LVEF measurement)
• If measured by echocardiography, the LV end-diastolic diameter must be ≥ 60 mm
• The duration of the QRS is \< 120 ms
• They are in sinus rhythm
• They cannot walk more than 400 meters during the screening 6-minute walk test (the patients must be limited by heart failure symptoms)

You may not qualify if:

• Patients with an indication for permanent ventricular pacing or with chronotropic insufficiency defined as follow:
• 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 for the duration of the study
• Second or third degree AV block, either persistent or intermittent
• Patients with a pacemaker or an ICD who are paced in the ventricular chamber more than 5% of the time
• Patients with LV dysfunction associated with a reversible cause such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)
• Patients who had a myocardial infarction within the past 6 weeks\* defined by 2 of the 3 following conditions:
• Prolonged chest pain
• ECG changes suggesting of AMI
• Cardiac enzymes elevation more than twice the local upper limit of normal)
• Patients who had cardiac surgery within the past 6 weeks\*
• Patients with moderate or severe cardiac valve stenosis (aortic, mitral, pulmonary or tricuspid)
• Patients with an inability or a limitation to walk for reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthrosis)
• Patients with severe coexisting illnesses making survival \> 6 months unlikely
• Patients who are pregnant and/or nursing.
• Patients with inability or unwillingness to consent or comply with follow-up requirements

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

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, L8L 2X2, 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

CHUM-Hôpital Hotel-Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Sacre-Coeur Hospital

Montreal, Quebec, H4J 1C5, Canada

Location

Montreal Heart Institute Research Center

Montreal, Quebec, HIT1C8, Canada

Location

Institut Univ de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Thibault B, Harel F, Ducharme A, White M, Ellenbogen KA, Frasure-Smith N, Roy D, Philippon F, Dorian P, Talajic M, Dubuc M, Guerra PG, Macle L, Rivard L, Andrade J, Khairy P; LESSER-EARTH Investigators. Cardiac resynchronization therapy in patients with heart failure and a QRS complex <120 milliseconds: the Evaluation of Resynchronization Therapy for Heart Failure (LESSER-EARTH) trial. Circulation. 2013 Feb 26;127(8):873-81. doi: 10.1161/CIRCULATIONAHA.112.001239. Epub 2013 Feb 6.

  PMID: 23388213 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bernard Thibault, MD

  Montreal Heart Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: October 1, 2003
• Primary Completion: February 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

CA (11)