Aiming at the appropriate target for the treatment of pulmonary hypertension due to left heart disease
Key result
Sildenafil treatment in patients with persistent pulmonary hypertension after valvular correction was associated with worse clinical outcomes than placebo.
Why the study?
Does sildenafil improve a composite clinical score in stable adult patients with persistent pulmonary hypertension after correction of valvular heart disease?
Population
200 stable adult patients with mean PAP ≥30 mmHg, who had undergone a successful valve replacement or repair…
Comparison
Sildenafil 40 mg oral three times daily for 6… vs Placebo for 6 months
Design
Editorial, 1:1, double-blind, placebo-controlled
Follow-up
6 months
Authors
Discussion
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Member takes
Implication
Sildenafil worsens clinical outcomes in patients with persistent pulmonary hypertension after valvular correction, reinforcing guidelines against using PAH-approved therapies in PH-LHD.
Study Design
Type
RCT (n=200)
Blinding
Double-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
Does sildenafil improve a composite clinical score in stable adult patients with persistent pulmonary hypertension after correction of valvular heart disease?
P
Population
200 stable adult patients with persistent pulmonary hypertension (mean PAP ≥30 mmHg) at least 1 year after successful valve replacement or repair, followed for 6 months.
I
Intervention
Sildenafil 40 mg oral three times daily (t.i.d) for 6 months
C
Comparator
Placebo for 6 months
O
Outcome
Composite clinical score combining death, hospital admission for heart failure, change in functional class, and patient global self-assessmentcomposite
Sildenafil worsens clinical outcomes in patients with persistent pulmonary hypertension after valvular correction, reinforcing guidelines against using PAH-approved therapies in PH-LHD.
Cite This Study
Galiè et al. (2017) conducted an RCT in Persistent pulmonary hypertension after correction of valvular heart disease (n=200). Sildenafil vs. Placebo was evaluated on Composite clinical score combining death, hospital admission for heart failure, change in functional class, and patient global self-assessment. Sildenafil treatment in patients with persistent pulmonary hypertension after valvular correction was associated with worse clinical outcomes than placebo.