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NCT04499196 Clinical Trial

Glucocorticoids and Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:
Prospective Study of Glucocorticoids as a Mechanism to Treat Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04499196
Other study ID # LD2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 29, 2020
Est. completion date July 29, 2022

Study information
Verified date March 2022
Source Washington University School of Medicine
Contact Manish Aggarwal, MD
Phone 314-273-8329
Email maggarwal@wustl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pediatric idiopathic pulmonary hypertension has significant morbidity and mortality. An ever expanding body of knowledge indicates the important contribution of inflammation to pathogenesis and successful treatment with glucocorticoids. Over the last several years the investigators have utilized steroids in patients with severe pulmonary hypertension as part of a treatment regimen. These basic science studies possibly identifies a biochemical etiology for the development of disease and may also be impacted by the administration of steroids. Additionally, there is a commercially available assay which tests for all of the above molecules.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date July 29, 2022
Est. primary completion date July 29, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria: - premature, BPD, >36 wga - pulmonary hypertension evidence by echocardiogram Exclusion Criteria: - poor ventilation/oxygenation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GlucoCorticoid
Administering glucocorticoid

Locations
Country Name City State
United States St. Louis Children's Hospital Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (9)

Aggarwal M, Grady RM. Glucocorticoids for treating paediatric pulmonary hypertension: a novel use for a common medication. Cardiol Young. 2017 Sep;27(7):1410-1412. doi: 10.1017/S1047951117000464. Epub 2017 May 16. — View Citation

Langleben D, Reid LM. Effect of methylprednisolone on monocrotaline-induced pulmonary vascular disease and right ventricular hypertrophy. Lab Invest. 1985 Mar;52(3):298-303. — View Citation

Ogawa A, Nakamura K, Matsubara H, Fujio H, Ikeda T, Kobayashi K, Miyazaki I, Asanuma M, Miyaji K, Miura D, Kusano KF, Date H, Ohe T. Prednisolone inhibits proliferation of cultured pulmonary artery smooth muscle cells of patients with idiopathic pulmonary arterial hypertension. Circulation. 2005 Sep 20;112(12):1806-12. Epub 2005 Sep 12. Erratum in: Circulation. 2006 Apr 18;113(15):e713. — View Citation

Ogawa A, Nakamura K, Mizoguchi H, Fujii N, Fujio H, Kusano KF, Ohe T, Ito H. Prednisolone ameliorates idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2011 Jan 1;183(1):139-40. — View Citation

Perros F, Dorfmüller P, Montani D, Hammad H, Waelput W, Girerd B, Raymond N, Mercier O, Mussot S, Cohen-Kaminsky S, Humbert M, Lambrecht BN. Pulmonary lymphoid neogenesis in idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Feb 1;185(3):311-21. doi: 10.1164/rccm.201105-0927OC. Epub 2011 Nov 22. — View Citation

Savai R, Pullamsetti SS, Kolbe J, Bieniek E, Voswinckel R, Fink L, Scheed A, Ritter C, Dahal BK, Vater A, Klussmann S, Ghofrani HA, Weissmann N, Klepetko W, Banat GA, Seeger W, Grimminger F, Schermuly RT. Immune and inflammatory cell involvement in the pathology of idiopathic pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Nov 1;186(9):897-908. doi: 10.1164/rccm.201202-0335OC. Epub 2012 Sep 6. — View Citation

Stenmark KR, Meyrick B, Galie N, Mooi WJ, McMurtry IF. Animal models of pulmonary arterial hypertension: the hope for etiological discovery and pharmacological cure. Am J Physiol Lung Cell Mol Physiol. 2009 Dec;297(6):L1013-32. doi: 10.1152/ajplung.00217.2009. Epub 2009 Sep 11. Review. — View Citation

Tuder RM, Groves B, Badesch DB, Voelkel NF. Exuberant endothelial cell growth and elements of inflammation are present in plexiform lesions of pulmonary hypertension. Am J Pathol. 1994 Feb;144(2):275-85. — View Citation

Wang W, Wang YL, Chen XY, Li YT, Hao W, Jin YP, Han B. Dexamethasone attenuates development of monocrotaline-induced pulmonary arterial hypertension. Mol Biol Rep. 2011 Jun;38(5):3277-84. doi: 10.1007/s11033-010-0390-x. Epub 2011 Mar 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Echo estimation of RV pressure 5 days
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