Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial
Primary resultResult — go to the resultOdds ratio 0.39 95% CI 0.22–0.67Authors' conclusion
Treatment with sildenafil in patients with persistent PH after successfully corrected VHD is associated to worse clinical outcomes than placebo.
Study context
- Population
- Stable adults with persistent pulmonary hypertension (PH) (mean pulmonary artery pressure ≥ 30 mmHg) ≥1 year after successful valve replacement or repair
- Participants
- 200 adults
- Comparison
- Sildenafil vs placebo
- Sildenafiln = 104
- Placebon = 96reference
- Primary endpoint
- Composite clinical score:
- Death
- Heart failure (HF) admission
- Change in functional class
- Patient global self-assessment
- Follow-up
- 6 months
Methodological detailsmulticentre, parallel, placebo-controlled, double-blind
- Multicentre
- Parallel
- Placebo-controlled
- Double-blind
Primary result
As reported in the abstract
Odds ratio
0.39
95% CI 0.22–0.67
P < 0.001
By group
Sildenafil
- Improved composite score
- 27
- Worsened composite score
- 33
Placebo
- Improved composite score
- 44
- Worsened composite score
- 14
Improved composite score
Sildenafil27
Placebo44
Worsened composite score
Sildenafil33
Placebo14
Sildenafil vs Placebo
OR 0.39 (95% CI 0.22–0.67); P < 0.001
Further findings
Kaplan-Meier estimate
| Outcome | Sildenafil | Placebo | HR for death or HF admission (95% CI) | P value | |
|---|---|---|---|---|---|
| Survival without HF admission (Kaplan-Meier estimate)Worse with sildenafil | 0.76 | 0.86 | 2.0 (1.0–4.0) | log-rank P = 0.044 | |
| 0.20.5125HR for death or HF admission (log scale) |
6-min walk test distance, natriuretic peptides, Doppler-derived systolic pulmonary pressure
- Changes similar in both groups
Original publication
Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial. Eur Heart J. Published 21 December 2017. doi:10.
Summarised from the published abstract; every number is checked against it