SNEGOVIK.
| Methods |
Study design: two‐arm, individual, RCT Centres: not reported Start of enrolment: not reported End of enrolment: not reported Follow‐up: 3 months Run‐in period: not reported |
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| Participants |
Inclusion criteria: "in ambulatory patients (pts) with arterial hypertension and CHF and preserved systolic left ventricular (LV) function" "According including/exclusion criteria pts have had seated systolic BP(SBP)≤160mmHg and diastolic BP(DBP) ≤ 95mmHg at randomization." "with stable symptomatic CHF (NYHA class II‐III) as a result of arterial hypertension (AH) with preserved LV ejection fraction (EF) ≥ 50%" Exclusion criteria: not reported Randomised (N): 726 (416 intervention, 310 control) Withdrawn (N): not reported Lost to follow‐up (N): not reported Analysed (N): not reported Age not reported Sex not reported Ethnicity not reported Systolic blood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 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 |
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| Interventions |
Intervention: quinapril Comparator: "conventional treatment, recommended for CHF [congestive heart failure] and AH [arterial hypertension] treatment" Concomitant medication: not reported |
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| Outcomes |
Planned: unclear Reported: NYHA, 6MWD, clinical status, QoL (MLHFQ), 2D echocardiography, blood pressure |
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| Notes | Unable to find contact details to ask investigators for end scores for QoL, full publication of results and mortality data. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "were randomly assigned" but no detail |
| 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 conference abstract only |