Glucocorticoids and Pulmonary Hypertension

NCT04499196 | Unknown

• 1 other identifier: LD2020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension Due to Lung Diseases and Hypoxia; Pulmonary Hypertension; Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• Echo estimation of RV pressure

  5 days

Interventions

GlucoCorticoid DRUG

Administering glucocorticoid

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

neonates with BPD

You may qualify if:

• premature, BPD, \>36 wga
• pulmonary hypertension evidence by echocardiogram

You may not qualify if:

• poor ventilation/oxygenation

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (9)

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  PMID: 7508683 BACKGROUND

• Perros F, Dorfmuller 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.

  PMID: 22108206 BACKGROUND

• 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.

  PMID: 22955318 BACKGROUND

• 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.

  PMID: 19748998 BACKGROUND

• 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.

  PMID: 3156262 BACKGROUND

• 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.

  PMID: 21431360 BACKGROUND

• 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. doi: 10.1164/ajrccm.183.1.139. No abstract available.

  PMID: 21193794 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.105.536169. Epub 2005 Sep 12.

  PMID: 16157769 BACKGROUND

• 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.

  PMID: 28506331 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Hypertension, Pulmonary; Bronchopulmonary Dysplasia

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Manish Aggarwal, MD

CONTACT

314-273-8329; maggarwal@wustl.edu

Ronald M Grady, MD

CONTACT

314-454-6095; rmgrady@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 5, 2020
• Study Start: July 29, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)