None listed
Conditions
Interventions
At each centre, randomisation was stratified based on
concurrent use of ß-blockers to account for potential increased use of these drugs with changes in clinical practice. We limited the proportion of randomised patients receiving ß -blockers to 25% in the protocol, but this limit was not reached. All other treatments were allowed, apart from open-label ACE inhibitors or angiotensin II antagonists, while patients were taking the
study drugs. After a run-in period of 1–28 days of single-bl
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: Aged 60 years or older (that 85% be aged >65 years) with NYHA class II–IV heart failure and left-ventricular ejection fraction of 40% or less, measured by echocardiography or radionuclear ventriculography. Naïve to ACE-inhibitor and angiotensin-II-antagonist. Some patients were eligible, however, if such treatment had been recently started and the exposure period was 7 days or less within the 3 months before randomisation.
Exclusion criteria
Exclusion criteria: Intolerance of ACE inhibitors or angiotensin-II-receptor antagonists; systolic blood pressure less than 90 mm Hg; diastolic pressure more than 95 mm Hg; haemodynamically important stenotic valvular heart disease; active myocarditits or pericarditis; automatic implanted cardioverter defibrillators; coronary angioplasty within 1 week of enrolment; coronoary artery bypass graft surgery, acute myocardial infarction, or unstable angina pectoris within 2 weeks of enrolment; cerebrovascular accident or transient ischaemic attack within 6 weeks of enrolment; documented or suspected significant renal artery stenosis; haematuria; and serum creatinine concentrations higher than 220 umol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The analysed the primary endpoint of death from any cause by time to event. The hazard rate, CI, and test for differences between treatments were based on Cox’s regression model (terms included in the model: treatment group, geographical region, and stratification level based on-blocker use at randomisation). Measure:Mortality from any cause Timepoints:At the end of the 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Were assessed at a significance level of 5%, Equal that (Primary outcome). Measure:Sudden death or Resuscitated arrest Timepoints:At the end of the 18 months | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed