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.
Yu
Cheuk-Man
CM
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. cmyu@cuhk.edu.hk
Abraham
William T
WT
Bax
Jeroen
J
Chung
Eugene
E
Fedewa
Michelle
M
Ghio
Stefano
S
Leclercq
Christophe
C
León
Angel R
AR
Merlino
John
J
Nihoyannopoulos
Petros
P
Notabartolo
Dean
D
Sun
Jing Ping
JP
Tavazzi
Luigi
L
D001208:Asia; D015150:Echocardiography, Doppler; D004554:Electric Countershock; D023381:Endpoint Determination; D005060:Europe; D005544:Forecasting; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D018579:Patient Selection; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome; D014481:United States; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging / Q000628:therapy*; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling