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Effect of phosphodiesterase-5 inhibition on SystEmic Right VEntricular size and function. A multicentre, double-blind, randomized, placebo-controlled trial: SERVE.
Greutmann, Matthias; Tobler, Daniel; Engel, Reto; Heg, Dik; Mueller, Christian; Frenk, André; Gabriel, Harald; Rutz, Tobias; Buechel, Ronny R; Willhelm, Matthias; Trachsel, Lukas; Freese, Michael; Ruperti-Repilado, Francisco Javier; Valsangiacomo Buechel, Emanuela; Beitzke, Dietrich; Haaf, Philip; Wustmann, Kerstin; Schwitz, Fabienne; Possner, Mathias; Schwitter, Juerg; Bouchardy, Judith; Schwerzmann, Markus.
Afiliación
  • Greutmann M; University Heart Center, Department of cardiology, University of Zurich, Zürich, Switzerland.
  • Tobler D; Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
  • Engel R; Department of Cardiology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
  • Heg D; CTU Bern, University of Bern, Bern, Switzerland.
  • Mueller C; Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.
  • Frenk A; Department of Cardiology, Center for Congenital Heart Disease, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Gabriel H; Department of Cardiology, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.
  • Rutz T; Service of Cardiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Buechel RR; Cardiac MR Center of the University Hospital Lausanne and CMR Corelab (swissCVIcorelab, CHUV), Lausanne, Switzerland.
  • Willhelm M; Department of Nuclear Medicine, Cardiac Imaging, University Hospital Zurich, Zurich, Switzerland.
  • Trachsel L; University Clinic of Cardiology, Preventive Cardiology and Sports Medicine, Inselspital, University Hospital, University of Bern, Bern, Switzerland.
  • Freese M; University Clinic of Cardiology, Preventive Cardiology and Sports Medicine, Inselspital, University Hospital, University of Bern, Bern, Switzerland.
  • Ruperti-Repilado FJ; Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.
  • Valsangiacomo Buechel E; Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
  • Beitzke D; Department of Cardiology, University Children's Hospital, University of Zurich, Zurich, Switzerland.
  • Haaf P; Department of Biomedical Imaging and Image-Guided Therapy, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.
  • Wustmann K; Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
  • Schwitz F; Cardiac MR Center of the University Hospital Lausanne and CMR Corelab (swissCVIcorelab, CHUV), Lausanne, Switzerland.
  • Possner M; Department of Cardiology, Center for Congenital Heart Disease, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Schwitter J; University Heart Center, Department of cardiology, University of Zurich, Zürich, Switzerland.
  • Bouchardy J; Service of Cardiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Schwerzmann M; Cardiac MR Center of the University Hospital Lausanne and CMR Corelab (swissCVIcorelab, CHUV), Lausanne, Switzerland.
Eur J Heart Fail ; 25(7): 1105-1114, 2023 07.
Article en En | MEDLINE | ID: mdl-37264734
AIMS: In adults with congenital heart disease and systemic right ventricles, progressive right ventricular systolic dysfunction is common and is associated with adverse outcomes. Our aim was to assess the impact of the phosphodiesterase-5-inhibitor tadalafil on right ventricular systolic function. METHODS AND RESULTS: This was a double-blind, randomized, placebo-controlled, multicentre superiority trial (NCT03049540) involving 100 adults with systemic right ventricles (33 women, mean age: 40.7 ± 10.7 years), comparing tadalafil 20 mg once daily versus placebo (1:1 ratio). The primary endpoint was the change in right ventricular end-systolic volume after 3 years of therapy. Secondary endpoints were changes in right ventricular ejection fraction, exercise capacity and N-terminal pro-B-type natriuretic peptide concentration. Primary endpoint assessment by intention to treat analysis at 3 years of follow-up was possible in 83 patients (42 patients in the tadalafil group and 41 patients in the placebo group). No significant changes over time in right ventricular end-systolic volumes were observed in the tadalafil and the placebo group, and no significant differences between treatment groups (3.4 ml, 95% confidence interval -4.3 to 11.0, p = 0.39). No significant changes over time were observed for the pre-specified secondary endpoints for the entire study population, without differences between the tadalafil and the placebo group. CONCLUSIONS: In this trial in adults with systemic right ventricles, right ventricular systolic function, exercise capacity and neuro-hormonal activation remained stable over a 3-year follow-up period. No significant treatment effect of tadalafil was observed. Further research is needed to find effective treatment for improvement of ventricular function in adults with systemic right ventricles.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Transposición de los Grandes Vasos / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: Eur J Heart Fail Asunto de la revista: CARDIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Transposición de los Grandes Vasos / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: Eur J Heart Fail Asunto de la revista: CARDIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido