Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) (EchoCRT)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Ventricular Dyssynchrony	Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)	Phase 2; Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1680 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Study Start Date :	August 2008
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	March 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: CRT=ON; Cardiac Resynchronization Therapy activated.	Device: 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.; Other Name: Lumax HF-T CRT-D system
Active Comparator: CRT=OFF; Cardiac Resynchronization Therapy deactivated.	Device: 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.; Other Name: Lumax HF-T CRT-D system

Outcome Measures

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Primary Outcome Measures :

1. Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death [ Time Frame: 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 ]
   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.
2. Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free) [ Time Frame: 6 months ]
   The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.

Secondary Outcome Measures :

1. Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year) [ Time Frame: Study duration from randomization to study exit ]
   Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
2. New York Heart Association (NYHA) Classification Change [ Time Frame: 6 months ]

   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.

3. Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up [ Time Frame: Changes between baseline and 6 months ]
   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.
4. Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL) [ Time Frame: Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months) ]

   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.

5. Number of Subjects With All-cause Mortality [ Time Frame: From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years ]
   Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

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Locations

United States, California
John Muir Medical Center
Concord, California, United States, 94520
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Desert Cardiology
Rancho Mirage, California, United States, 92270
University of California San Francisco
San Francisco, California, United States, 94143
Cardiology Associates Medical Group
Ventura, California, United States, 93003
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Osceola Regional Medical Center
Kissimmee, Florida, United States, 34741
University of Miami
Miami, Florida, United States, 33136
Tampa General Hospital
Tampa, Florida, United States, 33606
Tampa General Medical Center
Tampa, Florida, United States
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University
Atlanta, Georgia, United States, 30322
Saint Joseph's Hospital
Atlanta, Georgia, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
St. Francis Medical Group
Indianapolis, Indiana, United States, 46237
Community Heart and Vascular
Indianapolis, Indiana, United States, 46250
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Boston Medical Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Boston Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
Michigan Heart, P.C./ St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
United Heart and Vascular Center
Saint Paul, Minnesota, United States, 55102
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States
United States, Missouri
Kansas City Heart Foundation
Kansas City, Missouri, United States, 64132
Research Medical Center
Kansas City, Missouri, United States, 64132
Research Medical Center
Kansas City, Missouri, United States
Washington University
Saint Louis, Missouri, United States, 63102
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
St. Lukes-Roosevelt Hospital Center
New York, New York, United States, 10025
University of Rochester
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States, 28203
Duke University
Durham, North Carolina, United States
United States, Ohio
Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44145
The Ohio State University Richard M. Ross Heart Hospital
Columbus, Ohio, United States, 43210
Promedica Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States, 43615
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, United States, 18103
Drexel Cardiology
Philadelphia, Pennsylvania, United States, 19107
Jefferson Heart Institute, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
South Carolina Heart Center
Columbia, South Carolina, United States, 29204
United States, Tennessee
The Stern Cardiovascular Center
Memphis, Tennessee, United States, 38138
United States, Texas
Cardiology Center of Amarillo
Amarillo, Texas, United States, 79106
Texas Cardiac Arrhythmia
Austin, Texas, United States, 78705
Cardiology Associates of Corpus Christi
Corpus Christi, Texas, United States, 78404
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
INOVA Fairfax Hospital
Falls Church, Virginia, United States, 22042
Bon Secours Heart & Vascular Institute
Mechanicsville, Virginia, United States, 23116
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23225
Bon Secours Heart & Vascular Institute
Richmond, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Cardiovascular Associates Ltd
Virginia Beach, Virginia, United States, 23454
United States, Washington
Kootenai Heart Clinics
Spokane, Washington, United States, 99204
United States, Wisconsin
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States, 53215
Australia
Flinders Medical Center Adelaide
Adelaide, Australia
Princess Alexandra Hospital
Brisbane, Australia
St. Vincent's Hospital
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedland, Australia
Royal Perth Hospital
Perth, Australia
Austria
LKH Universitatsklinikum Graz
Graz, Austria
Belgium
OLV Hospital (OLV Ziekenhuis) Aalst
Aalst, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Canada, Ontario
UHN Toronto General Hospital
Toronto, Ontario, Canada
Canada
Edmonton Cardiology
Edmonton, Canada
Czechia
Olomouc University Hospital
Olomouc, Czechia
IKEM - Institute for Clinical and Experimental Medicine
Prague, Czechia
Na Homolce Hospital
Prague, Czechia
Denmark
Aalborg Sygehus
Aalborg, Denmark
Skejby Sygehus Aarhus
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
France
Nouvelles Cliniques Nantes
Nantes, France
CHU Pontchaillou de Rennes
Rennes, France
CHU Charles Nicolle
Rouen, France
Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Charite Campus Virchow Klinikum
Berlin, Germany
Judisches Krankenhaus Berlin
Berlin, Germany
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
Bernau, Germany
Alfried Krupp Krankenhaus
Essen, Germany
Elisabeth-Krankenhaus Essen
Essen, Germany
Westdeutsches Herzzentrum Essen
Essen, Germany
Asklepios Klinik St. Georg Hamburg
Hamburg, Germany
Universitares Herzzentrum Hamburg GmbH
Hamburg, Germany
Universitatsklinikum Jena
Jena, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
St. Marien Hospital Lunen
Lunen, Germany
Klinikum Lüdenscheid
Lüdenscheid, Germany
University Hospital of Magdeburg
Magdeburg, Germany
Israel
Barzilai Medical Center
Ashkelon, Israel
Soroka Medical Center
Beer Sheva, Israel
Hadassah Medical Organization
Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Hashomer, Israel
Italy
A.O.U. Consorziale Policlinico di Bari
Bari, Italy
A.O. Spedali Civili di Brescia
Brescia, Italy
P.O. Santa Maria di Loreto Nuovo
Naples, Italy
A.O.U. Maggiore della Carita
Novara, Italy
Netherlands
VU MC Amsterdam
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Poland
Instytut Kardiologii
Warsaw, Poland
4 Wojskowy Szpital Kliniczny
Wroclaw, Poland
Portugal
Hospital Santa Maria de Lisboa
Lisbon, Portugal
Hospital Santa Marta
Lisbon, Portugal
Spain
University of Alicante General Hospital
Alicante, Spain
Hospital Clinic of Barcelona
Barcelona, Spain
Switzerland
Hopitaux Universitaires de Geneve
Geneve, Switzerland
CHU Vaudois Lausanne
Lausanne, Switzerland
Triemli Hospital (Stadtspital Triemli)
Zurich, Switzerland
University of Zurich Hospital
Zurich, Switzerland
United Kingdom
University Hospitals of Coventry and Warwickshire
Coventry, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
St. George's Hospital
London, United Kingdom
St. Thomas' Hospital
London, United Kingdom
Russells Hall Hospital
West Midlands, United Kingdom

Sponsors and Collaborators

Biotronik, Inc.

University of Zurich

Investigators

Study Chair:	Frank Ruschitzka, MD	University of Zurich, Switzerland
Study Chair:	Johannes Holzmeister, MD	University of Zurich, Switzerland
Principal Investigator:	William Abraham, MD	Principal Investigator (USA) at The Ohio State University, OH, USA
Principal Investigator:	Jagmeet Singh, MD	Principal Investigator (USA) at Massachusetts General Hospital, MA, USA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tayal B, Gorcsan J 3rd, Bax JJ, Risum N, Olsen NT, Singh JP, Abraham WT, Borer JS, Dickstein K, Gras D, Krum H, Brugada J, Robertson M, Ford I, Holzmeister J, Ruschitzka F, Sogaard P. Cardiac Resynchronization Therapy in Patients With Heart Failure and Narrow QRS Complexes. J Am Coll Cardiol. 2018 Mar 27;71(12):1325-1333. doi: 10.1016/j.jacc.2018.01.042.

Steffel J, Varma N, Robertson M, Singh JP, Bax JJ, Borer JS, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J, Brugada J, Abraham WT, Ruschitzka F. Effect of Gender on Outcomes After Cardiac Resynchronization Therapy in Patients With a Narrow QRS Complex: A Subgroup Analysis of the EchoCRT Trial. Circ Arrhythm Electrophysiol. 2016 Jun;9(6). pii: e003924. doi: 10.1161/CIRCEP.115.003924.

Ruschitzka F, Abraham WT, Singh JP, Bax JJ, Borer JS, Brugada J, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J; EchoCRT Study Group. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N Engl J Med. 2013 Oct 10;369(15):1395-405. doi: 10.1056/NEJMoa1306687. Epub 2013 Sep 2.

Responsible Party:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00683696 History of Changes
Other Study ID Numbers:	EchoCRT
First Posted:	May 23, 2008
Results First Posted:	April 17, 2014
Last Update Posted:	January 17, 2018
Last Verified:	January 2018

Keywords provided by Biotronik, Inc.:

Cardiac Resynchronization Therapy; Heart Failure; Ventricular Dyssynchrony; Mechanical Dyssynchrony; Intraventricular Dyssynchrony	Echocardiography; Normal QRS; Heart Disease; EchoCRT

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases