NCT00960895

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

4 months

First QC Date

August 17, 2009

Last Update Submit

October 26, 2011

Conditions

LymphangioleiomyomatosisPulmonary Hypertension

Keywords

LymphangioleiomyomatosisPulmonary hypertension

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

You may not qualify if:

  • Post capillary pulmonary hypertension
  • Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease)
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Pradel Hospital

Lyon, University of Lyon, 69677, France

Location

MeSH Terms

Conditions

LymphangioleiomyomatosisHypertension, Pulmonary

Condition Hierarchy (Ancestors)

LymphangiomyomaNeoplasm, Lymphatic TissueNeoplasms by Histologic TypeNeoplasmsPerivascular Epithelioid Cell NeoplasmsNeoplasms, Connective and Soft TissueLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Vincent Cottin, MD

    University of Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr Cottin, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

FR(1)