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NCT00960895 Clinical Trial

Pulmonary Hypertension in Lymphangioleiomyomatosis

Pulmonary Hypertension Clinical Trial

— LAM-PH  

Official title:
Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00960895
Other study ID # GERMOP-001
Secondary ID
Status Completed
Phase N/A
First received August 17, 2009
Last updated October 26, 2011
Start date August 2009
Est. completion date December 2010

Study information
Verified date October 2011
Source Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Contact n/a
Is FDA regulated No
Health authority France: Institutional Ethical Committee
Study type Observational

Clinical Trial Summary

This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.

Description:

Descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension This will include modality of diagnosis of lLymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis

- Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)

Exclusion Criteria:

- Post capillary pulmonary hypertension

- Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease)

- Not willing to participate

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Louis Pradel Hospital Lyon University of Lyon

Sponsors (2)
Lead Sponsor Collaborator
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

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