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Heart FailurePhase 4EARTHNCT00900549

Evaluation of Resynchronization Therapy for Heart Failure

A Phase 4 study testing CRT on and CRT off in people with Heart Failure, run by Montreal Heart Institute at 11 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
CRT on and CRT off
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
11 sitesCanada
Study dates
Oct 2003to Jul 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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:
Show all 17Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • CHUS-Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton Health Sciences Center

    Hamilton, Ontario, L8L 2X2

  • CHUM-Hôpital Hotel-Dieu

    Montreal, Quebec, H2W 1T8

  • Sacre-Coeur Hospital

    Montreal, Quebec, H4J 1C5

  • Montreal Heart Institute Research Center

    Montreal, Quebec, HIT1C8

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Institut Univ de Cardiologie et de Pneumologie de Québec

    Québec, Quebec, G1V 4G5

  • Sunnybrook & Women's Hospital

    Toronto, Ontario, M4N 3M5

  • St-Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: EvaluAtion of Resynchronization Therapy for Heart Failure (EARTH)

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).

Read the 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.

Conditions
Heart Failure
Being tested
CRT on, CRT off
Keywords
Heart failure, Cardiac resynchronization therapy, ICD
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRT onDevice

    12 months

  • CRT offDevice

    12-month

Study groups in NCT00900549
Study groupRoleWhat they receive
CRTExperimentalNot described
Receives: Device: CRT on
No CRTSham comparatorNot described
Receives: Device: CRT off

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one year

Secondary outcomes (1)

  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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2009 (estimated)
  2. Study startOct 2003
  3. Primary completionFeb 2011
  4. Study completionJul 2011

Why it stopped: Futility reason, no difference between study groups

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00900549
Sponsor's protocol ID
UCT67914 (Lesser Earth)
Other IDs
ISRCTN 42560370
Acronym
EARTH
Status last verified
Jul 2011
First submitted
12 May 2009
Last updated
21 Jul 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23388213

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CRT on and CRT off in people with Heart Failure, run by Montreal Heart Institute at 11 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Futility reason, no difference between study groups). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00900549, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.

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