Aronow 1997.
Study characteristics | ||
Methods |
Study design: parallel RCT Centres: not reported Start of enrolment: not reported End of enrolment: not reported Mean follow‐up: 32 months (intervention), 31 months (control) Run‐in period: not reported |
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Participants |
Inclusion criteria: "≥ 62 years of age with New York Heart Association functional class II or III CHF, prior Qwave myocardial infarction, and a LV ejection fraction ≥ 40% after 2 months of treatment with diuretics and ACE inhibitors were included in the study." Exclusion criteria: "No patient had valvular heart disease, systolic blood pressure < 100 mm Hg, lung disease with bronchospasm, hepatic disease, renal insufficiency, sinus bradycardia, greater than first‐degree atrioventricular block, or severe peripheral arterial disease." Randomised (N): 158 (79 intervention, 79 control) Withdrawn (N): not reported Lost to follow‐up (N): not reported Analysed (N): 158 (79 intervention, 79 control) Age (years, mean, SD): intervention: 81, 8; control: 81, 7 Sex (% men): intervention: 29; control: 30 Ethnicity (%): not reported Systolic blood pressure not reported Heart rate not reported BMI not reported Serum creatinine not reported B‐type natriuretic peptide not reported NT pro B‐type natriuretic peptide (pg/mL): LVEF (%, mean, SD): intervention: 56, 11; control: 57, 11 NYHA class I (%): 0 NYHA class II (%): intervention: 53; control: 51 NYHA class III (%): intervention: 47; control: 49 NYHA class IV (%): 0 Hypertension (%): intervention: 67; control: 65 Diabetes: not reported Atrial fibrillation (%): intervention: 33; control: 34 Hospitalisation for HF: not reported Coronary heart disease (%): 100 Stroke not reported Diuretic (%): 100 Digoxin (%): intervention: 33; control: 34 Beta‐blocker study drug ACEI (%): 100 ARB not reported MRA not reported |
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Interventions |
Intervention: propranolol. "The initial dose of propranolol was 10 mg/day. This dose was increased by 10‐mg increments at 10‐day intervals until a dose of 30 mg 3 times daily was given. All patients treated with propranolol received a final daily dose of propranolol of 30 mg 3 times daily." Comparator: no treatment Concomitant medication: "All patients continued diuretic and ACE inhibitor therapy during the study. Digoxin was administered only if the patient had atrial fibrillation." |
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Outcomes |
Planned: no published protocol or clinical trial registry entry Reported: "total mortality and total mortality plus nonfatal myocardial infarction" |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | not reported |
Allocation concealment (selection bias) | Unclear risk | not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "LV ejection fraction and LV mass were interpreted by an experienced echocardiographer (IK) who was unaware of the study medications" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT analyses |
Selective reporting (reporting bias) | Unclear risk | not reported |
Other bias | Unclear risk | funding not reported |