Evidence map›Paper›PMID 29281101›Full record

Trial reportEuropean heart journal2018

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

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 and 17 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00862043 (Sildenafil for Improving Outcomes After Valvular Correction), which is not on this map. Cited by 106 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 5 pooled it
17.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00862043 phase4completednot on this map

Sildenafil for Improving Outcomes After Valvular Correction

TypeinterventionalSponsorHospital General Universitario Gregorio MarañonRan2009 to 2016Enrolled200ConditionsPulmonary Hypertension, Valvular Heart DiseaseArmsSildenafil Citrate, Placebo
3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 5 syntheses or guidelines pooled it, 223 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Phosphodiesterase 5 inhibitors for pulmonary hypertension.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Pressure gradient vs. flow relationships in patients with symptomatic valvular aortic stenosis - PREFLOW.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  16. Diagnosing post-capillary hypertension in patients with left heart disease: impact of new guidelines.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  17. Article
  18. Article
  19. Review
  20. Article

46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 12 institutions in 1 country.

Javier BermejoDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, and CIBERCV. Dr Esquerdo 46. 28007 Madrid, Spain.
Raquel YottiDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, and CIBERCV. Dr Esquerdo 46. 28007 Madrid, Spain.
Rocío García-OrtaHospital Virgen de las Nieves, Granada.
Pedro L Sánchez-FernándezHospital Clínico Universitario de Salamanca, and CIBERCV Salamanca.
Mario CastañoHospital Universitario de León, León.
Javier Segovia-CuberoHospital Puerta de Hierro Majadahonda and CIBERCV, Majadahonda.
Pilar Escribano-SubíasHospital 12 de Octubre and CIBERCV, Madrid, Spain.
José Alberto San RománHospital Clínico de Valladolid and CIBERCV, Valladolid.
Xavier BorrásHospital Santa Creu i San Pau and CIBERCV, Barcelona.
Angel Alonso-GómezHospital Universitario de Araba-Txagorritxu, Vitoria.
Javier BotasHospital Universitario Fundación Alcorcón, Alcorcón.
María G Crespo-LeiroComplejo Hospitalario Universitario de A Coruña and CIBERCV, A Coruña.
Sonia VelascoHospital de Galdakao-Usansolo, Usansolo.
Antoni Bayés-GenísHospital Universitari Germans Trias i Pujol and CIBERCV, Badalona.
Amador LópezHospital Universitario Reina Sofía, Córdoba.
Roberto Muñoz-AguileraHospital Infanta Leonor, Madrid.
Eduardo de TeresaHospital Virgen de la Victoria and CIBERCV, Málaga.
José R González-JuanateyHospital Clínico de Santiago de Compostela and CIBERCV, Santiago de Compostela.
Arturo EvangelistaHospital Universitario de la Vall d'Hebron and CIBERCV, Barcelona.
Teresa MombielaDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, and CIBERCV. Dr Esquerdo 46. 28007 Madrid, Spain.
Ana González-MansillaDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, and CIBERCV. Dr Esquerdo 46. 28007 Madrid, Spain.
Jaime ElízagaDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, and CIBERCV. Dr Esquerdo 46. 28007 Madrid, Spain.
Javier Martín-MoreirasHospital Clínico Universitario de Salamanca, and CIBERCV Salamanca.
José M González-SantosHospital Clínico Universitario de Salamanca, and CIBERCV Salamanca.
Eduardo Moreno-EscobarHospital Universitario San Cecilio, Granada, Spain.
Francisco Fernández-AvilésDepartment of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, and CIBERCV. Dr Esquerdo 46. 28007 Madrid, Spain.
Sildenafil for Improving Outcomes after VAlvular Correction (SIOVAC) investigators
Centro de Investigación en Red en Enfermedades Cardiovasculares · ESUniversidad Complutense de Madrid · ESHospital Txagorritxu · ESHospital Universitario Virgen de las Nieves · ESInstituto de Investigación Biosanitaria de Granada · ESHospital de Galdakao · ESHospital de León · ESHospital Universitario Fundación Alcorcón · ESHospital Universitario Reina Sofía · ESHospital Universitari Germans Trias i Pujol · ESHospital Universitario Infanta Leonor · ESComplexo Hospitalario Universitario A Coruña · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. The trial is registered with ClinicalTrials.gov, number NCT00862043.

Indexed as

AgedDouble-Blind MethodFemaleHeart FailureHeart Valve DiseasesHumansHypertension, PulmonaryMalePlacebosPulmonary Wedge PressureSildenafil CitrateTreatment OutcomeVasodilator AgentsPlacebosSildenafil CitrateVasodilator Agents

Identifiers

PMID29281101
PMCPMC5905634
OpenAlexW2806263607

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.