Shu 2005.
| Methods |
Study design: two‐arm, individual, RCT Centres: not reported Start of enrolment: August 2000 End of enrolment: March 2002 Follow‐up: 6‐12 months Run‐in period: not reported |
|
| Participants |
Inclusion criteria: "Patients were included in the study if they had (1) a history of uncorrected rheumatic heart valvular disease or New York Heart Association (NYHA) functional class III or IV disease, necessitating hospitalization; (2) a cardiothoracic ratio of less than 65%; (3) AF with a resting ventricular rate of 70 beats/ minute or more for at least three months, as depicted on the electrocardiogram (ECG); and (4) an echocardiogram showing a significant mitral stenosis or aortic lesions and mitral valve regurgitation." Exclusion criteria: "Patients were excluded from the study if they had uncorrected congenital heart disease, sustained ventricular tachycardia, severe liver and kidney dysfunction, chronic obstructive pulmonary disease, bronchial asthma, obstructive or restrictive cardiomyopathy or myocarditis, myocardial infarction, or unstable angina within the previous three months. Patients were also ineligible for enrollment if they required intensive care or concurrent intravenous therapy or if they were using calcium‐channel blockers, class I or III antiarrhythmic drugs, monoamine oxidase (MAO)–inhibitors or beta2‐agonists." Randomised (N): 88 (not reported by treatment arm) Withdrawn (N): 20 (did not complete the study) intervention: 11 (5 due to suspected adverse drug effects); control: 9 Lost to follow‐up (N): 14 (excluded from the evaluation at follow‐up ‐ 7 had insufficient quality of echocardiography or difficulties with telephone‐connection) Analysed (N): 67 (intervention: 33; control: 34) Age (years, mean, SD): intervention: 40.6, 6.8; control: 43.5, 7.4 Sex (% male): intervention: 36; control: 35 Ethnicity not reported Systolic blood pressure (mmHg, mean, SD): intervention: 115, 12; control: 121, 14 Heart rate not reported BMI not reported Serum creatinine not reported B‐type natriuretic peptide not reported NT pro B‐type natriuretic peptide not reported LVEF not reported NYHA class not reported Hypertension not reported Diabetes not reported Atrial fibrillation not reported Hospitalisation for heart failure: not reported Coronary heart disease not reported Stroke not reported Diuretic not reported Digoxin not reported Beta‐blocker not reported ACEI not reported ARB not reported MRA not reported |
|
| Interventions |
Intervention: Bisoprolol, "All patients in the treatment group received bisoprolol at the initial dose of 1.25 mg/day. The recommended maximal dose was 10 mg/day. The dose schedule for titration of the selective beta1 blocker was gradually increased over three to five days, by two to three weeks, to as high as 10 mg/day, with adjustments of diuretics and ACE‐inhibitors, as clinically indicated." Comparator: "control" (unspecified) Concomitant medication: "At the discretion of the treating physicians, all patients were given concomitant therapy consisting of one of the following: • diuretics, as required, to control fluid retention • digoxin, extracted from Digitalis lanata • ACE‐inhibitors (or ARBs when ACE‐inhibitors were not tolerated) unless there were specific contraindications • nitrates, depending on the presence of valvular lesions and on blood pressure readings" |
|
| Outcomes | Planned: we did not identify a published protocol or pre‐registered clinical trial register record | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "On the basis of admission sequence, patients were randomly assigned to a treatment group or a control group" |
| 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 | not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | unclear reporting of withdrawals/loss‐to‐follow up |
| Selective reporting (reporting bias) | Unclear risk | unable to assess |
| Other bias | Unclear risk | no funding source reported |