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. 2019 Jan 31;2019(1):CD012621. doi: 10.1002/14651858.CD012621.pub2

Han 2013.

Methods Double‐blind, placebo‐controlled trial
12 weeks duration
Participants Inclusion criteria:
  • Consensus criteria‐defined IPF and CO diffusing capacity < 35% predicted

  • Evidence of right ventricular hypertrophy or right ventricular dysfunction.


Exclusion criteria:
  • Resting oxygen saturation < 92% on 6 L of supplemental oxygen

  • Aortic stenosis

  • Idiopathic hypertrophic subaortic stenosis

  • Severe heart failure (left‐sided VEF < 25%) (WHO Group 3)


N = 119
Interventions Oral sildenafil (20 mg 3 times a day) (N=56) compared with placebo (N=63)
Outcomes 6MWD
 SGRQ
SF‐36
EuroQol visual analogue scores
Notes This was a substudy of the STEP‐IPF study which examined all participants with IPF and compared sildenafil with placebo
This substudy examined only those with pulmonary hypertension and IPF
Industry‐funded
Trial conducted at 14 centres in the USA, dates of enrolment not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants meeting eligibility criteria were randomly assigned in a 1:1 ratio to receive sildenafil or matched placebo with the use of a permuted‐block design, with stratification according to clinical centre
Allocation concealment (selection bias) Low risk Placebo‐controlled
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo‐controlled
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All echocardiograms were performed prior to randomisation and scored independently and in a blinded fashion by two cardiologists with advanced expertise in echocardiography.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "Sixty‐one echocardiograms could not be transferred to the study centre, thus ineligible for inclusion".
Selective reporting (reporting bias) High risk This is a substudy
Other bias Low risk Other bias is unlikely