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Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial
dc.contributor.author | Bermejo, Javier | |
dc.contributor.author | Yotti, Raquel | |
dc.contributor.author | García-Orta, Rocío | |
dc.contributor.author | Sánchez-Fernández, Pedro L. | |
dc.contributor.author | Castaño, Mario | |
dc.contributor.author | Segovia-Cubero, Javier | |
dc.contributor.author | Escribano-Subías, Pilar | |
dc.contributor.author | San Román, José Alberto | |
dc.contributor.author | Borrás, Xavier | |
dc.contributor.author | Alonso-Gómez, Ángel | |
dc.contributor.author | Botas, Javier | |
dc.contributor.author | Crespo-Leiro, María Generosa | |
dc.contributor.author | Velasco, Sonia | |
dc.contributor.author | Bayés-Genís, Antoni | |
dc.contributor.author | López, Amador | |
dc.contributor.author | Muñoz-Aguilera, Roberto | |
dc.contributor.author | Teresa, Eduardo de | |
dc.contributor.author | González-Juataney, José R. | |
dc.contributor.author | Evangelista, Arturo | |
dc.contributor.author | Mombiela, Teresa | |
dc.contributor.author | González-Mansilla, Ana | |
dc.contributor.author | Elízaga, Jaime | |
dc.contributor.author | Martín-Moreiras, Javier | |
dc.contributor.author | González-Santos, José M. | |
dc.contributor.author | Moreno-Escobar, Eduardo | |
dc.contributor.author | Fernández-Avilés, Francisco | |
dc.date.accessioned | 2024-06-14T09:26:32Z | |
dc.date.available | 2024-06-14T09:26:32Z | |
dc.date.issued | 2018-04-14 | |
dc.identifier.citation | Bermejo J, Yotti R, García-Orta R, Sánchez-Fernández PL, Castaño M, Segovia-Cubero J, Escribano-Subías P, San Román JA, Borrás X, Alonso-Gómez A, Botas J, Crespo-Leiro MG, Velasco S, Bayés-Genís A, López A, Muñoz-Aguilera R, de Teresa E, González-Juanatey JR, Evangelista A, Mombiela T, González-Mansilla A, Elízaga J, Martín-Moreiras J, González-Santos JM, Moreno-Escobar E, Fernández-Avilés F; Sildenafil for Improving Outcomes after VAlvular Correction (SIOVAC) investigators. 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. 2018 Apr 14;39(15):1255-1264. | es_ES |
dc.identifier.issn | 0195-668X | |
dc.identifier.uri | http://hdl.handle.net/2183/36930 | |
dc.description | Randomized controlled trial | es_ES |
dc.description.abstract | [Abstract] 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. | es_ES |
dc.description.sponsorship | This study was supported by the Instituto de Salud Carlos III, Ministerio de Economía y Competitividad, Spain, and the EU –European Regional Development Fund (EC07/90772) as well as by the Red de Investigación Cardiovascular and CIBERCV. | es_ES |
dc.description.sponsorship | Instituto de Salud Carlos III; EC07/90772 | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Oxford University Press | es_ES |
dc.relation.uri | https://doi.org/10.1093/eurheartj/ehx700 | es_ES |
dc.rights | Creative Commons Attribution-NonCommercial 4.0 International License (CC-BY-NC 4.0) | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | * |
dc.subject | Sildenafil | es_ES |
dc.subject | Pulmonary hypertension | es_ES |
dc.subject | Valvular heart disease | es_ES |
dc.subject | Heart failure | es_ES |
dc.title | Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.rights.access | info:eu-repo/semantics/openAccess | es_ES |
UDC.journalTitle | European Heart Journal | es_ES |
UDC.volume | 39 | es_ES |
UDC.issue | 15 | es_ES |
UDC.startPage | 1255 | es_ES |
UDC.endPage | 1264 | es_ES |
dc.identifier.doi | 10.1093/eurheartj/ehx700 |
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