Sahoo 2016.
| Methods |
Study design: RCT Centres: 1, India Start of enrolment: not reported End of enrolment: not reported Mean follow‐up: 3‐6 months Run‐in period: not reported |
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| Participants |
Inclusion criteria: "Patients with moderate or severe MR on color flow Doppler, LVEF ≥ 55%, and LV end‐systolic dimension < 40 mm were included" Exclusion criteria: "Patients with NYHA class IV symptoms, known coronary artery disease, significant other valvular disease, serum creatinine > 2.5 mg/dL, and hypertension were excluded" Randomised (N): 100 (48 intervention, 52 control) Withdrawn not reported Lost to follow‐up not reported Analysed (N): at 3 months: 100 (48 intervention, 52 control); at 6 months: 75 (39 intervention, 36 control) Age (years, mean, SD): intervention: 30.24, 12.76; control: 29.6, 15.58 Sex (% men): intervention: 35.6; control: 22.7 Ethnicity (%): not reported Systolic blood pressure (mmHg, mean, SD): intervention: 125, 10.1; control: 124.4, 7.4 Heart rate (beats/min, mean, SD): intervention: 90.1, 11.78; control: 88.5, 18.12 BMI: intervention: 21.04, 4.74; control: 19.04, 4.7 Serum creatinine not reported B‐type natriuretic peptide (pg/mL): intervention: 194, 178.5; control: 166, 165.7 NT pro B‐type natriuretic peptide (pg/mL): not reported LVEF (%, mean, SD): intervention: 62.5, 6.5; control: 61.4, 6.9 NYHA class: "most patients were in NYHA class II (77%) while 23% were in NYHA class III" Hypertension (%): intervention: 61.1; control: 62.3 Diabetes (%): intervention: 26.9; control: 25.3 Atrial fibrillation (%): intervention: 33.8; control: 35.5 Hospitalisation for heart failure: not reported Coronary heart disease (%): intervention: 68.9; control: 67.6 Stroke (%): intervention: 0.1; control: 0 Diuretic (%): 92 Digoxin (%): 33 Beta‐blocker (%): study drug ACEI (%): 58 ARB (%): not reported MRA (%): not reported |
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| Interventions |
Intervention: metoprolol succinate. "initiated at 12.5–25 mg/day and titrated as tolerated at 2‐week intervals to a maximum of 100 mg/day. Prior to each escalation, care was taken to ensure that resting heart rate was > 60 bpm and systolic BP > 100 mm Hg" Comparator: placebo Concomitant medication: "in addition to ongoing therapy" |
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| Outcomes |
Planned: unclear as we did not identify a published protocol or clinical trial registry entry Reported: withdrawals due to adverse events, echocardiographic outcomes, blood pressure, MR grade, NYHA class |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "by a computerized random number generating protocol" |
| 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 | Low risk | "Detailed echocardiography […] was performed by two operators who were blinded to the treatment protocol." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | unclear loss‐to‐follow up of 25 participants at 6 months as no reasons given |
| Selective reporting (reporting bias) | Unclear risk | unable to assess |
| Other bias | Unclear risk | "The authors declare no conflict of interest" no funding source reported |