Rationale and design of the Canadian Continuous Positive Airway Pressure Trial for Congestive Heart Failure patients with Central Sleep Apnea--CANPAP.

摘要

BACKGROUND: Cheyne-Stokes respiration with central sleep apnea (CSR-CSA) is commonly observed in patients with congestive heart failure (CHF), in which it is an independent risk factor for death. Treating CSR-CSA may, therefore, improve outcomes in patients with CHF. OBJECTIVE: The Canadian Continuous Positive Airway Pressure Trial for Congestive Heart Failure Patients with Central Sleep Apnea (CANPAP) is a multicentre, randomized, controlled clinical trial designed to test the hypothesis that treating CSR-CSA with continuous positive airway pressure (CPAP) will reduce the combined rate of all-cause mortality and cardiac transplantation in patients with CHF. Secondary outcomes include the severity of CSR-CSA, left ventricular volumes and function, submaximal exercise capacity, quality of life and hospital admissions. PATIENTS AND METHODS: The aim is to enroll 408 patients with CHF (New York Heart Association class II to IV and left ventricular ejection fraction of less than 40%) and CSR-CSA over a five-year period. Patients are randomly assigned to either standard medical therapy for CHF or standard medical therapy plus CPAP. The trial has 80% power to detect a 35% between-group treatment difference for the all-cause mortality-cardiac transplantation rate. Substudies will assess the role of oximetry as a screening tool for detecting CSR-CSA in patients with CHF, and the effects of CPAP on cardiac arrhythmias and plasma concentrations of natriuretic peptides and catecholamines. CONCLUSIONS: The CANPAP trial will help to define the role of CPAP better as a nonpharmacological intervention for the treatment of patients with CHF who have CSR-CSA.