治疗慢性心衰药物临床试验指导原则-EMEA.docVIP

The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 16 December 1999 CPMP/EWP/235/95, Rev 1COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMPNOTE FOR GUIDANCE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE TREATMENT OF CARDIAC FAILUREDISCUSSION IN THE EFFICACY WORKING PARTY (EWP TRANSMISSION TO THE CPMP RELEASE FOR CONSULTATION DEADLINE FOR COMMENTS RE-DISCUSSION AT THE EWP ADOPTION BY THE CPMP DATE FOR COMING INTO OPERATIONApril 1998 -January 1999February 1999February 1999August 1999September 1999 -November 1999December 1999June 2000Note: This revised Note for Guidance will replace the previous guideline, adopted inNovember 1995. 7 Westferry Circus, Canary Wharf, London E14 4HB, UK CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE TREATMENT OF CARDIAC FAILURE This note is intended to provide guidance for the clinical investigation of medicinal productsin the treatment of cardiac failure. It should be read in conjunction with Part 3 of the Annexof Directive 75/318/EEC, as amended, and all other relevant guidelines as applicable and isintended to assist in its application. 1. INTRODUCTION Cardiac failure (CF is a clinical syndrome caused by an abnormality of the heart and manifestas symptoms and signs on exercise and ultimately at rest. Objective evidence of cardiacdysfunction is also necessary for the diagnosis of cardiac failure. High output heart failure is not considered in this guideline because the primaryabnormality is not the heart and its function is not reduced at rest; nor does this guidelineapply to asymptomatic left ventricular dysfunction. Cardiac failure is a heterogeneous syndrome with a variety of causes. The abnormality of theheart may be related to primary impairment of myocardial function or to (chronic pressureand/or volume overload. Cardiac failure can be acute or chronic and usually becomesprogressively worse, the rate of this progression being dependent both on the primarypathology