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The Cardiac Resynchronization-Heart Failure (CARE-HF) trial [1] was a multicentre, international randomised trial whose aims were: 1. To assess the effect on morbidity and mortality of adding CRT to optimised pharmacological therapy in patients with moderate and severe heart failure (HF) due to left ventricular systolic dysfunction (LVSD) complicated by cardiac dyssynchrony (CD) 2. To investigate the mechanisms underlying the observed effect and to identify markers predicting success or failure of CRT. The main inclusion criteria were: chronic HF, NYHA class III/IV, with a high standard of pharmacological therapy, LVSD and dilation (EF ≤ 35% ; LVEDD ≥ 30 mm/heights in meters), cardiac dyssynchrony (QRS ≥ 150 ms or QRS ≥ 120 ms and two of the following echo criteria: aortic preejection delay ≥ 140 ms, interventricular mechanical delay ≥ 40 ms, delayed activation of the posterolateral LV wall). Between January 2001 and March 2003, 813 patients were enrolled at 82 European centres. Patient randomised to CRT (404) received a Medtronic Insync or Insync III device that provided atrial-biventricular stimulation (without backup ICD); the implant success rate was 96%. The primary endpoint was a composite of death from any cause or an unplanned hospitalisation for a major cardiovascular event. The principal secondary outcome was death from any cause, classified according to mode. At completion of the study (September 30, 2004) the rate of cross-over before primary endpoint was < 5%, survival status was ascertained on all patients |
