Adamyan 2010.
| Methods |
Study design: four arm factorial RCT Centres: not reported, assumed one, in Armenia Start of enrolment: not reported End of enrolment: not reported Mean follow‐up: 12 months Run‐in period: not reported |
|
| Participants |
Inclusion criteria: "III NYHA class chronic ischemic heart failure (CHF) patients (pts) with normal cholesterol who have preserved LV ejection fraction (PEF) and restrictive diastolic filling pattern" Exclusion criteria: not reported Randomised (N): 118 in total, of interest are: carvedilol, no simvastatin (N = 31) versus no carvedilol, no simvastatin (N = 28) Withdrawn (N): not reported Lost to follow‐up (N): not reported Analysed (N): not reported Age (years, mean, unspecified): 64.5, 0.3 Sex (% men): not reported Ethnicity (%): not reported Systolic blood pressure: not reported Heart rate: not reported BMI: not reported Serum creatinine: not reported B‐type natriuretic peptide (pg/mL): not reported NT pro B‐type natriuretic peptide (pg/mL): not reported LVEF "preserved LV ejection fraction" but not defined NYHA class I (%): 0 NYHA class II (%): 0 NYHA class III (%): 100 NYHA class IV (%): 0 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‐blockers: study drug ACEI: not reported ARB: not reported MRA: not reported |
|
| Interventions |
Intervention: carvedilol (up to 50 mg), simvastatin, carvedilol and simvastatin Comparator: not receiving carvedilol or simvastatin Concomitant medication: "in addition to ACE inhibitors, aldosterone antagonists and diuretics" |
|
| Outcomes |
Planned: not reported Reported: "prognosis, left ventricular (LV) diastolic function, plasma BNP level and inflammation status", "Assessment of relation of early (E) and late (A) diastolic filling velocities, deceleration time (DT) of E wave, levels of BNP, interleukin‐6 (IL‐6) and high sensitivity C‐reactive protein (CRP)", mortality, hospitalisation |
|
| Notes | Two conference abstracts only. Comparison between carvedilol and no treatment was of interest for this review. No outcome data relevant to this review. Trialists were contacted; no response. Source of funding: not reported. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly assigned" but no details given |
| 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 | Unclear risk | Not reported |
| Selective reporting (reporting bias) | Unclear risk | Not reported |
| Other bias | High risk | Published as conference abstracts only |