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Evaluation of Resynchronization Therapy for Heart Failure (EARTH)

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
CRT on
CRT off
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Cardiac resynchronization therapy, ICD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Patients participating in another study

The 6-week period is calculated prior to the beginning of the baseline evaluation and not the implant procedure itself. This difference comes from the fact that the protocol includes a delay of 2 to 8 weeks between the implant procedure and the actual beginning of the patient's evaluation.

Sites / Locations

  • University of Alberta Hospital
  • QEII Health Sciences Centre
  • Hamilton Health Sciences Center
  • University of Ottawa Heart Institute
  • Sunnybrook & Women's Hospital
  • St-Michael's Hospital
  • CHUS-Fleurimont
  • Montreal Heart Institute Research Center
  • CHUM-Hôpital Hotel-Dieu
  • Sacre-Coeur Hospital
  • Institut Univ de Cardiologie et de Pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CRT

No CRT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 12, 2009
Last Updated
July 20, 2011
Sponsor
Montreal Heart Institute
Collaborators
Abbott Medical Devices, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00900549
Brief Title
Evaluation of Resynchronization Therapy for Heart Failure
Acronym
EARTH
Official Title
EvaluAtion of Resynchronization Therapy for Heart Failure (EARTH)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Futility reason, no difference between study groups
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Montreal Heart Institute
Collaborators
Abbott Medical Devices, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Cardiac resynchronization therapy, ICD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRT
Arm Type
Experimental
Arm Title
No CRT
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
CRT on
Intervention Description
12 months
Intervention Type
Device
Intervention Name(s)
CRT off
Intervention Description
12-month
Primary Outcome Measure Information:
Title
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
Time Frame
one year
Secondary Outcome Measure Information:
Title
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Patients participating in another study The 6-week period is calculated prior to the beginning of the baseline evaluation and not the implant procedure itself. This difference comes from the fact that the protocol includes a delay of 2 to 8 weeks between the implant procedure and the actual beginning of the patient's evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Thibault, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Hamilton Health Sciences Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Sunnybrook & Women's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St-Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
CHUS-Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Montreal Heart Institute Research Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
HIT1C8
Country
Canada
Facility Name
CHUM-Hôpital Hotel-Dieu
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Sacre-Coeur Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Institut Univ de Cardiologie et de Pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23388213
Citation
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.
Results Reference
derived

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Evaluation of Resynchronization Therapy for Heart Failure

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