Hoendermis 2015.
Methods | Single‐centre, randomised double‐blind, placebo‐controlled trial 12 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
n = 52 |
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Interventions | Sildenafil, titrated to 60 mg 3 times a day (N=26), or placebo (N=26) | |
Outcomes | The primary endpoint was change in mean PAP after 12 weeks Secondary endpoints were change in mean PAWP, cardiac output, and peak oxygen consumption (peak VO2) | |
Notes | Publicly funded Trial conducted at University of Medical Center Groningen, Hanzeplein, The Netherlands, enrolled between October 2011 and September 2014 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Eligible patients were randomly assigned in a 1:1 ratio according to a computer‐generated random sequence to 1 of the 2 treatment groups using a block size of 4 |
Allocation concealment (selection bias) | Low risk | Sildenafil and matching placebo were administered orally in tablets and were provided by Pfizer Global Pharmaceuticals, were identical in appearance and were supplied to the study site in identical‐masked kits |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo was used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo was used |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were recorded, and were even across the groups. Quote: "One participant in the sildenafil group withdrew due to heart failure, and four discontinued due to adverse events". |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were accounted for |
Other bias | Low risk | Other bias is unlikely |