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Sildenafil Versus Placebo for Early Pulmonary Vascular Disease in Scleroderma (SEPVADIS): protocol for a randomized controlled trial.
Lammi, Matthew R; Mukherjee, Monica; Saketkoo, Lesley Ann; Carey, Kyle; Hummers, Laura; Hsu, Steven; Krishnan, Amita; Sandi, Marie; Shah, Ami A; Zimmerman, Stefan L; Hassoun, Paul M; Mathai, Steven C.
Afiliación
  • Lammi MR; Louisiana State University Health Sciences, 1901 Perdido St, 70112, New Orleans, LA,, USA. mlammi2@jh.edu.
  • Mukherjee M; Comprehensive Pulmonary Hypertension Center, University Medical Center, New Orleans, USA. mlammi2@jh.edu.
  • Saketkoo LA; New Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, USA. mlammi2@jh.edu.
  • Carey K; Johns Hopkins University, Division of Pulmonary and Critical Care Medicine, Baltimore, USA. mlammi2@jh.edu.
  • Hummers L; Division of Cardiology, Johns Hopkins University, Baltimore, USA.
  • Hsu S; New Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, USA.
  • Krishnan A; Tulane University School of Medicine, New Orleans, USA.
  • Sandi M; Institute for Clinical and Translational Medicine, Johns Hopkins University, Baltimore, USA.
  • Shah AA; Johns Hopkins University, Division of Rheumatology, Baltimore, USA.
  • Zimmerman SL; Division of Cardiology, Johns Hopkins University, Baltimore, USA.
  • Hassoun PM; Louisiana State University Health Sciences, 1901 Perdido St, 70112, New Orleans, LA,, USA.
  • Mathai SC; Comprehensive Pulmonary Hypertension Center, University Medical Center, New Orleans, USA.
BMC Pulm Med ; 24(1): 211, 2024 Apr 30.
Article en En | MEDLINE | ID: mdl-38689245
ABSTRACT

BACKGROUND:

Pulmonary hypertension (PH) is a leading cause of death in patients with systemic sclerosis (SSc). An important component of SSc patient management is early detection and treatment of PH. Recently the threshold for the diagnosis of PH has been lowered to a mean pulmonary artery pressure (mPAP) threshold of > 20 mmHg on right heart catheterization (RHC). However, it is unknown if PH-specific therapy is beneficial in SSc patients with mildly elevated pressure (SSc-MEP, mPAP 21-24 mmHg).

METHODS:

The SEPVADIS trial is a randomized, double-blind, placebo-controlled phase 2 trial of sildenafil in SSc-MEP patients with a target enrollment of 30 patients from two academic sites in the United States. The primary outcome is change in six-minute walk distance after 16 weeks of treatment. Secondary endpoints include change in pulmonary arterial compliance by RHC and right ventricular function by cardiac magnetic resonance imaging at 16 weeks. Echocardiography, serum N-terminal probrain natriuretic peptide, and health-related quality of life is being measured at 16 and 52 weeks.

DISCUSSION:

The SEPVADIS trial will be the first randomized study of sildenafil in SSc-MEP patients. The results of this trial will be used to inform a phase 3 study to investigate the efficacy of treating patients with mild elevations in mPAP. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04797286.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Esclerodermia Sistémica / Citrato de Sildenafil / Hipertensión Pulmonar Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: BMC Pulm Med Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Esclerodermia Sistémica / Citrato de Sildenafil / Hipertensión Pulmonar Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: BMC Pulm Med Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido