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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00683696




Registration number
NCT00683696
Ethics application status
Date submitted
30/08/2007
Date registered
23/05/2008
Date last updated
17/01/2018

Titles & IDs
Public title
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Scientific title
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Secondary ID [1] 0 0
EchoCRT
Universal Trial Number (UTN)
Trial acronym
EchoCRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Ventricular Dyssynchrony 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)

Experimental: CRT=ON - Cardiac Resynchronization Therapy activated.

Active Comparator: CRT=OFF - Cardiac Resynchronization Therapy deactivated.


Treatment: Devices: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death - The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.
Timepoint [1] 0 0
From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years
Primary outcome [2] 0 0
Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free) - The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year) - Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
Timepoint [1] 0 0
Study duration from randomization to study exit
Secondary outcome [2] 0 0
New York Heart Association (NYHA) Classification Change - Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.
NYHA classes:
Class I - Subjects with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation,dyspnea, or anginal pain.
Class II - Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III - Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV - Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up - Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. Therefore, a negative change in QOL score from baseline to 6 months represents an improvement in quality of life, while a positive change in QOL score from baseline to 6 months represents a worsening in quality of life.
Timepoint [3] 0 0
Changes between baseline and 6 months
Secondary outcome [4] 0 0
Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL) - Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.
This composite endpoint used a weighted scoring scale based on the African-American Heart Failure Trial (A-HeFT) study Endpoint Score. (Taylor, AL, Ziesche, S, Yancy, C, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. N Engl J Med 2004; 351:2049-57.)
Composite Endpoint Scoring:
Vital Status:
Death (-3),
Survival to end of trial (0),
Hospitalization:
1st hospitalization for HF (-1),
No hospitalization (0),
QOL score:*
Improvement by = 10 units (+2),
Improvement by 5-9 units (+1),
Change by < 5 units (0),
Worsening by 5-9 units (-1),
Worsening by = 10 (-2).
Possible total score -6 to +2.
*QOL score details are provided in Secondary Outcome Measure 5.
Timepoint [4] 0 0
Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)
Secondary outcome [5] 0 0
Number of Subjects With All-cause Mortality - Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
Timepoint [5] 0 0
From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years

Eligibility
Key inclusion criteria
- Men and women 18 years of age or older.

- Understand the nature of the procedure.

- Give written informed consent.

- Willing and able to complete all testing required by the clinical protocol.

- Indication for an implantable cardioverter defibrillator (ICD).

- NYHA class III-IV within the last three months prior to enrollment and at baseline (at
baseline only: also Stage C according to ACC/AHA guidelines).

- Stable optimal pharmacologic therapy for HF.

- An ejection fraction = 35% within one year prior to enrollment and confirmed on the
baseline echocardiogram.

- Increased left ventricular dimension, defined as LVEDD = 55 mm.

- Resting QRS duration < 130 ms evidenced by a historical 12-lead ECG prior to
enrollment and at baseline.

- Ventricular dyssynchrony assessed by echocardiography locally and confirmed by the
echo core lab. One of the two following criteria has to be present to include the
subject in the study:

- Intra-left ventricular dyssynchrony measured by color Tissue Doppler Imaging
(TDI) with an opposing wall delay of = 80 ms in the 4-chamber or apical long-axis
view.

- Speckle-tracking radial strain septal-posterior wall delay = 130 ms.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Implanted pacemaker or defibrillator with >10% ventricular pacing, as demonstrated by
device statistics averaged over at least the last three months prior to enrollment.

- Women who are pregnant, lactating, or planning to become pregnant during the course of
the trial.

- Bradycardia pacing indication.

- Surgically correctable primary valvular heart disease, i.e. aortic stenosis, torn
cordae, or flail segment.

- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon
and/or stent angioplasty) within the past 3 months prior to enrollment.

- Enzyme-positive myocardial infarction within the past 3 months prior to enrollment.

- Angiographic evidence of coronary disease, candidates for coronary revascularization
likely to undergo coronary artery bypass graft surgery or percutaneous coronary
intervention in the next 3 months.

- Irreversible brain damage from preexisting cerebral disease.

- Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.

- Permanent second or third degree heart block.

- Chagas disease.

- Persistent or paroxysmal atrial fibrillation within one month prior to enrollment.

- Expected to receive heart transplantation within six months.

- Current inotropic therapy.

- Acutely decompensated heart failure.

- Contrast dye allergy and unable or unwilling to undergo pretreatment with steroids
and/or diphenhydramine.

- Life expectancy of less than six months.

- Presence of any disease, other than the subject's cardiac disease associated with a
reduced likelihood of survival for the duration of the trial, (e.g. cancer).

- Significant renal insufficiency defined as a serum creatinine > 2.5 mg/dL (> 221
µmol/L) within the last four weeks prior to enrollment..

- Liver failure, defined as three times the upper limit of normal for aminotransferases.

- Participation in any other clinical trial.

- Unable to return for follow-up visits due to distance from the clinic.

- Do not anticipate being a resident of the area for the scheduled duration of the
trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center Adelaide - Adelaide
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedland
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Nedland
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
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California
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Connecticut
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North Carolina
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Oregon
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Texas
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Washington
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Wisconsin
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Austria
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Graz
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Aalst
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Edmonton
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Czechia
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Olomouc
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Prague
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Aalborg
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Aarhus
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Copenhagen
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Hellerup
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France
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Nantes
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France
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Rennes
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France
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Rouen
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Berlin
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Bernau
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Essen
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Jena
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Leipzig
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Lunen
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Lüdenscheid
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Magdeburg
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Jerusalem
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Bari
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Italy
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Brescia
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Italy
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Naples
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Novara
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Netherlands
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Amsterdam
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Leiden
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Poland
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Warsaw
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Wroclaw
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Portugal
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Lisbon
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Alicante
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Spain
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Barcelona
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Switzerland
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Geneve
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Lausanne
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Switzerland
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Zurich
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United Kingdom
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Coventry
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Leicester
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London
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United Kingdom
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Zurich
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on
mortality and morbidity of subjects with heart failure due to left ventricular systolic
dysfunction, already receiving optimized HF medication, with a narrow QRS width (< 130 ms)
and echocardiographic evidence of ventricular dyssynchrony.
Trial website
https://clinicaltrials.gov/show/NCT00683696
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frank Ruschitzka, MD
Address 0 0
University of Zurich, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00683696