Machado 2009.
Methods | Multicentre, placebo‐controlled, double‐blind trial 16 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
n = 74, with a planned study size of 132 |
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Interventions | Oral sildenafil 20 mg 3 times daily for 6 weeks,followed by 40 mg 3 times daily for 4 weeks, followed by 80 mg 3 times daily for 6 weeks, compared to placebo in a similarly uptitrated fashion | |
Outcomes | Primary outcome measures: Change in exercise capacity as assessed by 6MWD Secondary outcome measures: Change from baseline in PH at week 16 as assessed by tricuspid regurgitant jet velocity, Borg dyspnoea score, (severity is measured on a 10‐point scale with 0 = nothing at all and 10 = maximum severity of breathlessness), BNP levels. |
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Notes | The study was prematurely stopped due to a statistically significant increase in serious adverse events in the sildenafil arm Published as an abstract only, but also registered on the clinical trial registry: NCT00492531 Publicly funded Trial conducted at 10 United States and United Kingdom Centers, dates not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States randomised, but methods not clearly stated |
Allocation concealment (selection bias) | Low risk | Placebo‐controlled |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | States participants and personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | States investigators were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals and reasons for trial termination clearly described |
Selective reporting (reporting bias) | Low risk | Study was published despite early termination |
Other bias | Low risk | Risk of other bias is unlikely. Although this is an abstract only, further methods were published on the clinical trials registry |