OBJECTIVE: To evaluate the efficacy of tezosentan in reducing the incidence of right ventricular (RV) failure and associated mortality in patients with pre-existing pulmonary hypertension. The primary endpoint was the proportion of patients with RV failure during weaning from cardiopulmonary bypass (CPB), assessed 30 minutes after the end of CPB. DESIGN: Multicenter, double-blind, randomized, placebo-controlled trial. SETTING:Thirty-one cardiac surgical centers in 14 countries. PARTICIPANTS: Two hundred seventy-four patients with pulmonary hypertension aged ≥ 18 years scheduled to undergo cardiac surgery. INTERVENTION: Intravenous tezosentan (5 mg/h) during surgery and up to 24 hours afterwards (1 mg/h), or matched placebo. MEASUREMENTS AND MAIN RESULTS:One-hundred thirty-three patients receivedtezosentan and 141 placebo. RV failure occurred in 30 patients (10.9%), 37% of whom died. There was no difference in the incidence of RV failure between the two treatment groups (relative risk reduction: 0.07 [95% CI-0.83, 0.53; P = 0.8278]). CONCLUSION: A reduction in RV failure with tezosentan was not observed in this study.(Current Controlled Trials, identifier NCT00458276).
RCT Entities:
OBJECTIVE: To evaluate the efficacy of tezosentan in reducing the incidence of right ventricular (RV) failure and associated mortality in patients with pre-existing pulmonary hypertension. The primary endpoint was the proportion of patients with RV failure during weaning from cardiopulmonary bypass (CPB), assessed 30 minutes after the end of CPB. DESIGN: Multicenter, double-blind, randomized, placebo-controlled trial. SETTING: Thirty-one cardiac surgical centers in 14 countries. PARTICIPANTS: Two hundred seventy-four patients with pulmonary hypertension aged ≥ 18 years scheduled to undergo cardiac surgery. INTERVENTION: Intravenous tezosentan (5 mg/h) during surgery and up to 24 hours afterwards (1 mg/h), or matched placebo. MEASUREMENTS AND MAIN RESULTS: One-hundred thirty-three patients received tezosentan and 141 placebo. RV failure occurred in 30 patients (10.9%), 37% of whom died. There was no difference in the incidence of RV failure between the two treatment groups (relative risk reduction: 0.07 [95% CI-0.83, 0.53; P = 0.8278]). CONCLUSION: A reduction in RV failure with tezosentan was not observed in this study.(Current Controlled Trials, identifier NCT00458276).
Authors: Michael Winterhalter; Steffen Rex; Christian Stoppe; Peter Kienbaum; Hans-Helge Müller; Ines Kaufmann; Hermann Kuppe; Aristidis Dongas; Bernhard Zwissler Journal: Can J Anaesth Date: 2019-02-12 Impact factor: 5.063
Authors: André Y Denault; Jean S Bussières; Ramiro Arellano; Barry Finegan; Paul Gavra; François Haddad; Anne Q N Nguyen; France Varin; Annik Fortier; Sylvie Levesque; Yanfen Shi; Mahsa Elmi-Sarabi; Jean-Claude Tardif; Louis P Perrault; Jean Lambert Journal: Can J Anaesth Date: 2016-07-28 Impact factor: 6.713
Authors: Márton Tokodi; Endre Németh; Bálint K Lakatos; Erika Kispál; Zoltán Tősér; Levente Staub; Kristóf Rácz; Ádám Soltész; Szabolcs Szigeti; Tamás Varga; János Gál; Béla Merkely; Attila Kovács Journal: ESC Heart Fail Date: 2020-03-26