CONSENSUS TRIAL

Problem Heart failure (Stage IV)
Format Double-blinded multi-center RCT
Treatment Enalapril
Control Placebo
Population 253 patients
Inclusion criteria Patients with severe congestive heart failure (New York Heart Association [NYHA] functional class IV)
Exclusion criteria Acute pulmonary oedema
Hemodynamically important aortic or mitral-valve stenosis
Myocardial infarction within the previous two months
Unstable angina
Planned cardiac surgery
Right heart failure due to pulmonary disease
Serum creatinine concentration above 300 Î_mol per liter.
Follow-up Median 188 days
Primary endpoint Six-month mortality
Cause of death

(Cause of death was classified by two investigators independently, on the basis of detailed reports, before the code was broken. Causes of death were described in accordance with a modified version of the American Heart Association's recommendations. Sudden death was defined as death within one hour of the onset of new symptoms. Unwitnessed deaths were classified according to the length of time from the last observation when the patient was alive to the estimated time of death)
Secondary endpoint(s) 12-month and overall mortality during the entire trial period, according to the \intention-to-treat\" principle."
Details -
Brief summary: ACEi reduce CCF progression in NYHA 4, mortality, improve symptoms
PAPER: Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study
Date 4 Jun 1987
Journal N Engl J Med. 1987 Jun 4;316(23):1429-35.
Information Reductions in
-All-cause mortality
-NYHA classification
-CHF progression
No reduction in sudden cardiac death