[Reading of the trials in cardiac insufficiency; therapeutic studies (phases II B and III)]. / Lecture des essais dans l'insuffisance cardiaque; études thérapeutiques (phases II B et III).

ABSTRACT

The object of therapeutic trials in cardiac failure is to improve the quality of life by controlling the principal symptoms which are dyspnoea and tiredness on effort and to improve survival. A critical review of therapeutic trials in cardiac failure must examine whether these two objectives have been attained and if they are attained simultaneously. In some cases, there is symptomatic improvement but with decreased life expectancy whereas in others, survival is prolonged without adequate control of symptoms. A critical analysis should examine the pertinence of these criteria of efficacy, and confirm that the problem of survival has been assessed, that reliable data has been provided, that the study population is representative of the real population of the patients to be treated, and finally, that the experimental protocol is realistic, i.e. a prospective study with analysis of intention to treat.