HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION (HYPID-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02799771|
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : February 23, 2017
HYPID-2 study is an extension of HYPID study (NCT01443598) :
HYPID-2 is also an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization.
It concerns only incident patients (i.e patients included within 6 months after PH diagnosis) whereas HYPID concerned prevalent and incident cases.
The primary aim is the same than HYPID : identify prognostic factors
|Condition or disease|
|Pulmonary Arterial Hypertension Diffuse Interstitial Lung Disease|
Pre capillary pulmonary hypertension (PH) may be present in patients with diffuse interstitial lung disease.
In this context, PH represents an important factor of morbidity and mortality for these patients.
As in HYPID, the main purpose of HYPID-2 is to determine predictive factors of mortality within this cohort of incident patients (i.e patients included within 6 months after PH diagnosis).
In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of incident patients.
Each incident patient will be followed during 2 years at least.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Observational Study of Incident Patients With Pre Capillary Pulmonary Hypertension and Interstitial Lung Disease|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2022|
- Overall survival [ Time Frame: 2 years ]Determine predictive factors of mortality
- Progression-free survival [ Time Frame: 2 years ]Time to death or 10% decline in FVC
- Response to therapy [ Time Frame: 2 years ]Proposition of patients with 10% or more decline in PVR
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799771
|Contact: Vincent COTTIN, MDemail@example.com|
|Contact: Stéphanie POLAZZIfirstname.lastname@example.org|
|Louis Pradel Hospital (Bâtiment A4)||Recruiting|
|Lyon, Bron, France, 69677|
|Contact: Vincent COTTIN, MD 33-4-27-85-77-00 email@example.com|
|Contact: Sabrina ZEGHMAR 33-4-72-11-93-02 firstname.lastname@example.org|
|Principal Investigator:||Vincent COTTIN, MD||Hospices civils de Lyon / Université Lyon I|