Glucocorticoids and Pulmonary Hypertension

NCT ID: NCT04499196

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-29

Study Completion Date

2022-07-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GlucoCorticoid

Administering glucocorticoid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* poor ventilation/oxygenation
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Manish Aggarwal, MD

Role: CONTACT

314-273-8329

Ronald M Grady, MD

Role: CONTACT

314-454-6095

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Manish Aggarwal, MD

Role: primary

314-454-6095

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 7508683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22108206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22955318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19748998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3156262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21431360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21193794 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16157769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28506331 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LD2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Community Care for Croup (RCT)
NCT01042145 COMPLETED PHASE4