RT Journal Article
T1 Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial.
A1 Bermejo, Javier
A1 Yotti, Raquel
A1 García-Orta, Rocío
A1 Sánchez-Fernández, Pedro L
A1 Castaño, Mario
A1 Segovia-Cubero, Javier
A1 Escribano-Subías, Pilar
A1 San Román, José Alberto
A1 Borrás, Xavier
A1 Alonso-Gómez, Angel
A1 Botas, Javier
A1 Crespo-Leiro, María G
A1 Velasco, Sonia
A1 Bayés-Genís, Antoni
A1 López, Amador
A1 Muñoz-Aguilera, Roberto
A1 de Teresa, Eduardo
A1 González-Juanatey, José R
A1 Evangelista, Arturo
A1 Mombiela, Teresa
A1 González-Mansilla, Ana
A1 Elízaga, Jaime
A1 Martín-Moreiras, Javier
A1 González-Santos, José M
A1 Moreno-Escobar, Eduardo
A1 Fernández-Avilés, Francisco
A1 Sildenafil for Improving Outcomes after VAlvular Correction (SIOVAC) investigators, 
AB We aimed to determine whether treatment with sildenafil improves outcomes of patients with persistent pulmonary hypertension (PH) after correction of valvular heart disease (VHD). The sildenafil for improving outcomes after valvular correction (SIOVAC) study was a multricentric, randomized, parallel, and placebo-controlled trial that enrolled stable adults with mean pulmonary artery pressure ≥ 30 mmHg who had undergone a successful valve replacement or repair procedure at least 1 year before inclusion. We assigned 200 patients to receive sildenafil (40 mg three times daily, n = 104) or placebo (n = 96) for 6 months. The primary endpoint was the composite clinical score combining death, hospital admission for heart failure (HF), change in functional class, and patient global self-assessment. Only 27 patients receiving sildenafil improved their composite clinical score, as compared with 44 patients receiving placebo; in contrast 33 patients in the sildenafil group worsened their composite score, as compared with 14 in the placebo group [odds ratio 0.39; 95% confidence interval (CI) 0.22-0.67; P  Treatment with sildenafil in patients with persistent PH after successfully corrected VHD is associated to worse clinical outcomes than placebo. Off-label usage of sildenafil for treating this source of left heart disease PH should be avoided. The trial is registered with ClinicalTrials.gov, number NCT00862043.
YR 2018
FD 2018
LK http://hdl.handle.net/10668/11954
UL http://hdl.handle.net/10668/11954
LA en
DS RISalud
RD Sep 8, 2025