Predictors of response to cardiac resynchronization therapy (PROSPECT)--study design.

BACKGROUND Cardiac resynchronization therapy (CRT) is currently indicated in patients with moderate to severe heart failure, a wide QRS complex and significant left ventricular dysfunction despite optimal medical therapy. Adoption of these criteria for CRT results in a favorable response in only two thirds of candidates. METHODS "Predictors of response to cardiac resynchronization therapy (PROSPECT)," a prospective, multicenter, nonrandomized study, aims to identify echocardiographic measures of dyssynchrony and evaluate their ability to predict response to CRT. PROSPECT will enroll approximately 300 patients in up to 75 centers in the United States, Asia, and Europe with clinical follow-up for 6 months. We will prospectively and individually test a variety of conventional echocardiographic and tissue Doppler imaging parameters against measures of clinical response. The primary response criteria are improvement in the heart failure Clinical Composite Score and left ventricular reverse remodeling. Enrollment began in March 2004 and is expected to conclude early 2005.

[1]  D. Delurgio,et al.  Effect of Cardiac Resynchronization Therapy on Left Ventricular Size and Function in Chronic Heart Failure , 2003, Circulation.

[2]  H. Schieffer,et al.  Optimizing the AV Delay in DDD Pacemaker Patients with High Degree AV Block: Mitral Valve Doppler Versus Impedance Cardiography , 1997, Pacing and clinical electrophysiology : PACE.

[3]  J. Spinelli,et al.  Impact of cardiac resynchronization therapy using hemodynamically optimized pacing on left ventricular remodeling in patients with congestive heart failure and ventricular conduction disturbances. , 2001, Journal of the American College of Cardiology.

[4]  R. Kerber,et al.  ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). , 2002, Circulation.

[5]  Peter Søgaard,et al.  Tissue Doppler imaging predicts improved systolic performance and reversed left ventricular remodeling during long-term cardiac resynchronization therapy. , 2002, Journal of the American College of Cardiology.

[6]  Chu-Pak Lau,et al.  Tissue Doppler Echocardiographic Evidence of Reverse Remodeling and Improved Synchronicity by Simultaneously Delaying Regional Contraction After Biventricular Pacing Therapy in Heart Failure , 2002, Circulation.

[7]  Chu-Pak Lau,et al.  Predictors of left ventricular reverse remodeling after cardiac resynchronization therapy for heart failure secondary to idiopathic dilated or ischemic cardiomyopathy. , 2003, The American journal of cardiology.

[8]  D. Kass,et al.  Ventricular resynchronization: pathophysiology and identification of responders. , 2003, Reviews in cardiovascular medicine.

[9]  Catherine Klersy,et al.  Interventricular and intraventricular dyssynchrony are common in heart failure patients, regardless of QRS duration. , 2004, European heart journal.

[10]  S. Goodman,et al.  Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. , 2003, JAMA.

[11]  Randolph P. Martin,et al.  Usefulness of the peak velocity difference by tissue Doppler imaging technique as an effective predictor of response to cardiac resynchronization therapy. , 2004, The American journal of cardiology.

[12]  D. DeMets,et al.  Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. , 2004, The New England journal of medicine.

[13]  Quantitative two-dimensional echocardiographic measurements are major predictors of adverse cardiovascular events after acute myocardial infarction. The protective effects of captopril. , 1994, Circulation.

[14]  J. Daubert,et al.  Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. , 2001, The New England journal of medicine.

[15]  W. Remme.  The Carvedilol and ACE-Inhibitor Remodelling Mild Heart Failure Evaluation Trial (CARMEN)—Rationale and Design , 2004, Cardiovascular Drugs and Therapy.

[16]  R M Whitlock,et al.  Left ventricular end-systolic volume as the major determinant of survival after recovery from myocardial infarction. , 1987, Circulation.

[17]  R. Doughty,et al.  Left ventricular remodeling with carvedilol in patients with congestive heart failure due to ischemic heart disease , 1997 .

[18]  R. Canby,et al.  Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. , 2003, JAMA.

[19]  Jeroen J. Bax,et al.  Relationship Between QRS Duration and Left Ventricular Dyssynchrony in Patients with End‐Stage Heart Failure , 2004, Journal of cardiovascular electrophysiology.

[20]  A. Lazarus,et al.  Echocardiographic Modeling of Cardiac Dyssynchrony Before and During Multisite Stimulation: A Prospective Study , 2003, Pacing and clinical electrophysiology : PACE.

[21]  M. Packer,et al.  Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. , 2001, Journal of cardiac failure.

[22]  Michel Haissaguerre,et al.  Comparison of characteristics in responders versus nonresponders with biventricular pacing for drug-resistant congestive heart failure. , 2002, The American journal of cardiology.

[23]  Jeroen J. Bax,et al.  Left ventricular dyssynchrony predicts benefit of cardiac resynchronization therapy in patients with end-stage heart failure before pacemaker implantation. , 2003, The American journal of cardiology.

[24]  B. Kristensen,et al.  Sequential Versus Simultaneous Biventricular Resynchronization for Severe Heart Failure: Evaluation by Tissue Doppler Imaging , 2002, Circulation.

[25]  J. McMurray,et al.  Long-term effects of darusentan on left-ventricular remodelling and clinical outcomes in the EndothelinA Receptor Antagonist Trial in Heart Failure (EARTH): randomised, double-blind, placebo-controlled trial , 2004, The Lancet.

[26]  C. Leclercq,et al.  Cardiac resynchronization therapy in advanced heart failure the multicenter InSync clinical study ☆ , 2002, European journal of heart failure.

[27]  Paolo Rizzon,et al.  Clinical Application of Echocardiographic Findings Cardiac Resynchronization Therapy Tailored by Echocardiographic Evaluation of Ventricular Asynchrony , 2016 .

[28]  K. Adams,et al.  Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. , 1996, Circulation.

[29]  Yan Zhang,et al.  Tissue Doppler Imaging Is Superior to Strain Rate Imaging and Postsystolic Shortening on the Prediction of Reverse Remodeling in Both Ischemic and Nonischemic Heart Failure After Cardiac Resynchronization Therapy , 2004, Circulation.

[30]  W. Braham,et al.  Cardiac Resynchronization in Chronic Heart Failure , 2002 .

[31]  J. Sanderson,et al.  Fragile left atrial thrombus successfully treated with anticoagulants , 2003, Heart.