{"id":"55707ac58973","type":"article","url":"https://hartvaat.nl/2018/04/14/sildenafil-bij-persisterende-pulmonale-hypertensie-na-klepchirurgie/","title":"Sildenafil bij persisterende pulmonale hypertensie na klepchirurgie","title_en":"Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["pulmonale-hypertensie"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehx700","source_url":"https://doi.org/10.1093/eurheartj/ehx700","authors":["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"],"significance":6,"published":"2018-04-14","source_date":"2018-04-14","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/rechtsventrikelfalen/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:27:14Z","updated":"2026-07-03T13:26:29Z","licence":"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.","body_markdown":"Multicenter studie naar sildenafil bij patiënten met gecorrigeerd kleplijden en persisterende pulmonale hypertensie. Onderzoekt farmacologische reductie van residuele PH.","abstract_original":"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."}