# Sildenafil bij persisterende pulmonale hypertensie na klepchirurgie

*geplaatst 2018-04-14 · Hartfalen · European heart journal · doi 10.1093/eurheartj/ehx700 · https://hartvaat.nl/2018/04/14/sildenafil-bij-persisterende-pulmonale-hypertensie-na-klepchirurgie/*

Multicenter studie naar sildenafil bij patiënten met gecorrigeerd kleplijden en persisterende pulmonale hypertensie. Onderzoekt farmacologische reductie van residuele PH.

## English: Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial.

This multicenter study evaluated sildenafil for persistent pulmonary hypertension after corrected valvular heart disease, testing phosphodiesterase-5 inhibition for residual PH in the post-surgical setting.

## Abstract (original, from the publication)

AIMS: We aimed to determine whether treatment with sildenafil improves outcomes of patients with persistent pulmonary hypertension (PH) after correction of valvular heart disease (VHD). METHODS AND RESULTS: 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 < 0.001]. The Kaplan-Meier estimates for survival without admission due to HF were 0.76 and 0.86 in the sildenafil and placebo groups, respectively (hazard ratio 2.0, 95% CI = 1.0-4.0; log-rank P = 0.044). Changes in 6-min walk test distance, natriuretic peptides, and Doppler-derived systolic pulmonary pressure were similar in both groups. CONCLUSION: 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.

Auteurs: Javier Bermejo, Raquel Yotti, Rocío García-Orta, Pedro L Sánchez-Fernández, Mario Castaño, Javier Segovia-Cubero, Pilar Escribano-Subías, José Alberto San Román, Xavier Borrás, Angel Alonso-Gómez, Javier Botas, María G Crespo-Leiro, Sonia Velasco, Antoni Bayés-Genís, Amador López, Roberto Muñoz-Aguilera, Eduardo de Teresa, José R González-Juanatey, Arturo Evangelista, Teresa Mombiela, Ana González-Mansilla, Jaime Elízaga, Javier Martín-Moreiras, José M González-Santos, Eduardo Moreno-Escobar, Francisco Fernández-Avilés

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Bron: European heart journal, https://doi.org/10.1093/eurheartj/ehx700. Bijgewerkt 2026-07-03T13:26:29Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.