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. 2021 May 22;2021(5):CD012721. doi: 10.1002/14651858.CD012721.pub3

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
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Withdrawn (N): not reported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
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."
Outcomes Planned: no published protocol or clinical trial registry entry
Reported: "total mortality and total mortality plus nonfatal myocardial infarction"
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