EchoCRT

EchoCRT

Cardiac Resynchronization Therapy in Heart Failure with a Narrow QRS Complex

Ruschitzka et al., The New England Journal of Medicine 2013

Study Design

  • Randomized, prospective, parallel, double-blinded, multi-center, international trial
  • Evaluates the effects of CRT on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction with a narrow QRS width (
  • 1,680 enrolled, 809 randomized (404 patients to CRT and 405 to control) at 115 sites in 17 countries

Key Result 1

The primary outcome, death from any cause or hospitalization for worsening heart failure, occurred in 116 of 404 patients (28.7%) in the CRT group, as compared with 102 of 405 (25.2%) in the control group (hazard ratio with CRT, 1.20; 95% confidence interval [CI], 0.92 to 1.57; P = 0.15).

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Primary Composite Outcome

Key Result 2

The rate of freedom from complications related to the CRT-D system at 6 months was 89.6% for the population that included all patients who underwent an attempted implantation.1

Clinical Relevance

  • As compared with an ICD with inactivated CRT, a CRT-D did not reduce the rate of death from any cause or hospitalization for heart failure and may increase mortality among patients with systolic heart failure and a QRS duration of less than 130 msec¹
  • Our results reinforce the notion that, at least until new methods of assessment are developed, QRS width (with or without mechanical dyssynchrony) remains the primary determinant of response to CRT¹

Study Objective
  • Evaluates the effects of CRT on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving current standard HF medication (including a diuretic), with a narrow QRS width (<130 ms) and echocardiographic evidence of ventricular dyssynchrony
1° Endpoints
  • Evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of death or first hospitalization for worsening HF
  • Evaluate the complication-free rate of the Lumax HF-T CRT-D system in the narrow QRS patient population at 6 months
2° Endpoints
  • Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure
  • Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification
  • Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire
  • 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
  • Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group
Clinical Sites
  • 115 sites across 17 countries (United States, Canada, Israel, Australia, and Europe)
Sample Size
  • 809 randomized (404 patients to CRT and 405 to control)
Key Inclusion Criteria
  • 18 years of age or older, with New York Heart Association (NYHA) class III or IV heart failure
  • Left ventricular ejection fraction of 35% or less
  • Standard indication for an implantable cardioverter-defibrillator (ICD)
  • Stable medical therapy recommended by by current guidelines
  • QRS duration of less than 130 msec
  • Left ventricular end-diastolic diameter of 55 mm or more
  • Echocardiographic evidence of left ventricular dyssynchrony: tissue Doppler imaging opposing-wall delay in the peak systolic velocity of ≥80ms and/or speckle-tracking radial strain anteroseptal-posterior wall delay ≥130ms
Key Exclusion Criteria
  • Acute decompensated heart failure
  • Intravenous inotropic therapy
  • Atrial fibrillation within the previous month
  • Bradycardia requiring pacing
  • Details of the inclusion and exclusion criteria are povided in the Supplementary Appendix of the manuscript
Devices
  • Any BIOTRONIK CRT-D devices approved by the FDA (Lumax HF-T CRT-D)
  • Any legally marketed endocardial ICD and pacing leads
Follow-Up
  • 1-month, 3-month follow-ups, and clinical follow-up every 3 months thereafter
Study Duration
  • August 2008 - March 2013
Reference No.
  • NCT00683696
Principal Investigators
  • Johannes Holzmeister, MD, University of Zurich, Zurich, Switzerland
  • Frank Ruschitzka, MD, University of Zurich, Zurich, Switzerland
  • William T. Abraham, MD, The Ohio State University, Columbus, OH, United States

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Disclaimer
On March 13, 2013, the study was stopped on the recommendation of the data and safety monitoring board, on the basis of futility with a potential for harm.


1 Ruschitzka F, Abraham W, Singh J, Bax J, Borer J, Brugada J, Dickstein K, Ford I, Gorcsan J III, Gras D, Krum H, Sogaard P, Holzmeister J; Cardiac-Resynchronization Therapy in Heart Failure with a Narrow QRS Complex, New England Journal of Medicine, 2013; 369:1395-1405.