HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Patients newly diagnosed with:
  • - Pre capillary pulmonary hypertension at right heart sided catheterization with: mPAP > or = 25 mmHg, PCWP < or = 15 mmHg.
  • - Interstitial lung disease with diffuse infiltrative opacities on chest CT scan.

Exclusion Criteria:

  • - Pulmonary hypertension related to a thromboembolic disease.
  • - Respiratory disease other than diffuse interstitial lung disease.
  • - Any etiological factor of pulmonary arterial hypertension based on NICE 2013 classification other than diffuse interstitial lung disease.
- Any progressive disease associated to a life expectancy less than 6 months other than pulmonary hypertension, diffuse interstitial lung disease and respiratory insufficiency

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02799771
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vincent COTTIN, MD
Principal Investigator Affiliation Hospices civils de Lyon / Université Lyon I
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, Diffuse Interstitial Lung Disease
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Louis Pradel Hospital (Bâtiment A4), Lyon, Bron, France

Status

Address

Louis Pradel Hospital (Bâtiment A4)

Lyon, Bron, 69677

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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