Lewis 2007.
Methods | Randomised, parallel‐group, double‐blinded, single‐centre, placebo‐controlled trial 12 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
n = 34 |
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Interventions | Sildenafil (25 to 75 mg orally 3 times daily) (N=17) or placebo (N=17) | |
Outcomes | 6MWD Cardiopulmonary exercise test Haemodynamics using right‐heart catheterisation, including RAP, PCWP, CI, stroke volume, PVR, SVR Quality of life questionnaire including the Minnesota Heart Failure Questionnaire (a 21‐question self‐administered instrument in which scores can range from 0 to 5 for each question and higher scores indicate a poorer quality of life) Clinical worsening Mortality Adverse events |
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Notes | Public and industry funded Trial conducted at multiple centres (location not stated) from May 2003 to March 2006 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The Massachusetts General Hospital Pharmacy was responsible for the blinding and randomisation procedure |
Allocation concealment (selection bias) | Low risk | The Massachusetts General Hospital Pharmacy was responsible for the blinding and randomisation procedure |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The investigators adjudicated all primary and secondary endpoints and reviewed data on safety before unblinding of the study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is not clear whether there were any withdrawals; does not explicitly state that all recruited completed the trial |
Selective reporting (reporting bias) | Unclear risk | Prespecified outcomes were reported |
Other bias | Low risk | Other bias is unlikely |