Pulmonary Arterial HypertensionHYPIDNCT01443598
Pulmonary Hypertension in Interstitial Lung Disease
An observational study of Pulmonary Arterial Hypertension and Diffuse Interstitial Lung Disease, run by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires at 1 site in France.
Trial summary
HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Diffuse Interstitial Lung Disease
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pre capillary pulmonary hypertension and interstitial lung disease at HRCT
Who may be able to join
- 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
Who cannot join
- pulmonary hypertension related to a thromboembolic disease
- respiratory disease other than diffuse interstitial lung disease
- any etiological factor of pulmonary arterial hypertension based on DANA POINT 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 locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Patients With Pre Capillary Pulmonary Hypertension
HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors.
Read the detailed description
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.
One of the purposes of HYPID is to determine predictive factors of mortality within this cohort of patients.
In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of patients. Each patient will be followed during 2 years at least.
- Keywords
- Pulmonary arterial hypertension,, Interstitial lung disease at HRCT
- Medical subject headings
- Pulmonary Arterial Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Determine predictive factors of mortality
Measured: 2 years
Secondary outcomes (6)
Progression-free survival (1)
Determine cause of death
Measured: 2 years
Progression-free survival (2)
Determine survival and time to worsening
Measured: 2 years
Progression-free survival (3)
Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension
Measured: 2 years
Progression-free survival (4)
Document the efficacy of PH specific treatment
Measured: 2 years
Progression-free survival (5)
Evaluate the level of pulmonary arterial hypertension and compare the functional characteristics of patients with moderate or severe pulmonary hypertension
Measured: 2 years
Progression-free survival (6)
Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
- Investigators
- Vincent Cottin, MD, Principal investigator, Hospices Civils de Lyon / University Lyon I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443598
- Sponsor's protocol ID
- GERMOP-002
- Acronym
- HYPID
- Status last verified
- Jun 2016
- First submitted
- 28 Sep 2011
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Patients With Pre Capillary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01443598
- Acronym / sponsor ID
- HYPID / GERMOP-002
- Keywords
- Pulmonary arterial hypertension,, Interstitial lung disease at HRCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors.
Detailed description
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.
One of the purposes of HYPID is to determine predictive factors of mortality within this cohort of patients.
In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of patients. Each patient will be followed during 2 years at least.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pre capillary pulmonary hypertension and interstitial lung disease at HRCT
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- pulmonary hypertension related to a thromboembolic disease
- respiratory disease other than diffuse interstitial lung disease
- any etiological factor of pulmonary arterial hypertension based on DANA POINT 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 2 years
Determine predictive factors of mortality
6 secondary outcomes
Progression-free survival (1)
Time frame: 2 years
Progression-free survival (2)
Time frame: 2 years
Progression-free survival (3)
Time frame: 2 years
Progression-free survival (4)
Time frame: 2 years
Progression-free survival (5)
Time frame: 2 years
Progression-free survival (6)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- website National French Reference Center for rare lung diseasesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Arterial Hypertension
RecruitingPhase 2
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Pulmonary Arterial Hypertension
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
Active, not recruitingObservational study
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
Pulmonary Hypertension, Interstitial Lung Disease
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Cottin, MD principal investigator
Hospices Civils de Lyon / University Lyon I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Diffuse Interstitial Lung Disease, run by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.