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

Ovchinnov 2015.

Methods Randomised parallel‐group placebo‐controlled trial
12 weeks duration
Participants Inclusion criteria:
  • Participants with HFpEF (diagnosed by the ESC algorithm, 2007)

  • Reactive pulmonary hypertension (systolic pulmonary artery pressure ≥ 35 mmHg at rest and Doppler‐derived pulmonary vascular resistance > 3.0 units Wood)

  • On standard CHF therapy (WHO Group 2)


n = 50
Interventions Sildenafil (25 mg 3 times a day for 12 weeks followed by 50 mg 3e times a day for 12 weeks; n = 30) or to control group (no sildenafil, n = 20)
Outcomes 6MWD
Cycle ergometer exercise duration
Systolic pulmonary artery pressure
RV function assessed by tricuspid annular systolic excursion
Left‐sided diastolic function (E/é ratio)
Notes Quantitative outcomes were only reported for the sildenafil group; the trial reported "no improvement in control group was observed" so this trial was unable to be included in the meta‐analysis
We tried to contact all authors, but at the time of this review publication there has been no reply, or contact details were unavailable
Funding source not stated
Location and dates not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Paper states participants were randomly assigned, but no methods were given
Allocation concealment (selection bias) High risk Compared sildenafil to "no sildenafil" ‐ unclear if placebo was used
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unclear if placebo was used or if participants were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Unclear if outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk Number of completers were not reported. Mortality or loss to follow‐up were not reported. Methods using intention‐to‐treat or per‐protocol analysis was not specified
Selective reporting (reporting bias) High risk Quantitative outcome data were only reported for the sildenafil group, not placebo group, and no P values between groups were reported
Other bias Unclear risk Not clear if other bias is possible ‐ abstract from conference proceedings with limited data presented