Pulmonary Hypertension in Lymphangioleiomyomatosis | NCT00960895

Studies
Pulmonary Hypertension in Lymphangioleiomyomatosis

NCT00960895

Sponsor

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

Status

Completed

Last Update Posted

Oct 27, 2011Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Lymphangioleiomyomatosis
Pulmonary Hypertension

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 17, 2009

First Submission Date that Met QC Criteria

Aug 17, 2009

First Posted Date

Aug 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2011

Last Update Posted Date

Oct 27, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincent COTTIN, Pr Cottin, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires, Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Hospices Civils de Lyon	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent Cottin, MD	University of Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Louis Pradel Hospital		Lyon	University of Lyon	69677	France

Condition Browse Module

MeSH Terms

ID	Term
D018192	Lymphangioleiomyomatosis
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008203	Lymphangiomyoma
D018190	Neoplasm, Lymphatic Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided