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Evaluation of Resynchronization Therapy for Heart Failure (EARTH) (EARTH)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Device programming
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, resynchronisation, ICD

Eligibility Criteria

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

Inclusion Criteria (for Greater and Lesser EARTH):

Patient must answer "yes"

  1. Does the patient require an ICD or an ICD replacement?
  2. Does the patient have a documented 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 < 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?

Exclusion Criteria:

Patient must have answered "NO" to all of the exclusion criteria

  1. 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?
  2. 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)?
  3. Did the patient have myocardial infarction or cardiac surgery in the 6 weeks preceding the pre-implant visit?
  4. Does the patient have a moderate or severe cardiac valve stenosis?
  5. 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)?
  6. Does the patient have severe coexisting illnesses making survival > 6 months unlikely?
  7. Is the patient pregnant and/or nursing?
  8. Is the patient unable or unwilling to consent or to comply with follow-up requirements?
  9. Is the patient participating in another clinical study potentially interfering with the present trial?
  10. Does the patient have a resynchronization system in place?

Sites / Locations

  • University of Alberta Hospital
  • St-Paul's Hospital
  • QEII Health Sciences Centre
  • University of Ottawa Heart Institute
  • Sunnybrook & Women's Hospital
  • St-Michael's Hospital
  • CHUS-Fleurimont
  • Montreal Heart Institute
  • 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

Active Comparator

Active Comparator

Arm Label

LV Pacing

BV Pacing

Arm Description

left univentricular pacing

biventricular pacing

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2009
Last Updated
May 6, 2012
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
NCT00901212
Brief Title
Evaluation of Resynchronization Therapy for Heart Failure (EARTH)
Acronym
EARTH
Official Title
Evaluation fo Resynchronization Therapy for Heart Failure (EARTH)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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, resynchronisation, ICD

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LV Pacing
Arm Type
Active Comparator
Arm Description
left univentricular pacing
Arm Title
BV Pacing
Arm Type
Active Comparator
Arm Description
biventricular pacing
Intervention Type
Device
Intervention Name(s)
Device programming
Intervention Description
6-month period
Primary Outcome Measure Information:
Title
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)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Clinical, electrical, echocardiographic, MUGA scan endpoints, Neuro-hormones
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (for Greater and Lesser EARTH): 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? Exclusion Criteria: Patient must have answered "NO" to all of the exclusion criteria 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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard MD, Thibault
Organizational Affiliation
Montreal Heart Institute Research Center
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
St-Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
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
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T1C8
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
34953062
Citation
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.
Results Reference
derived
PubMed Identifier
22104549
Citation
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.
Results Reference
derived
PubMed Identifier
21791363
Citation
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.
Results Reference
derived

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Evaluation of Resynchronization Therapy for Heart Failure (EARTH)

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