Pulmonary Hypertension in Lymphangioleiomyomatosis (LAM-PH)

October 26, 2011 updated by: Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension

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

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • University of Lyon
      • Lyon, University of Lyon, France, 69677
        • Louis Pradel Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Lymphangioleiomyomatosis, 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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

Collaborators

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Vincent Cottin, MD, University of Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2011

Last Update Submitted That Met QC Criteria

October 26, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERMOP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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