Clinical Trials Logo
  1. Home
  2. Pulmonary Arterial Hypertension
  3. NCT01443598
  4. Details
NCT01443598 Clinical Trial

Pulmonary Hypertension in Interstitial Lung Disease

Pulmonary Arterial Hypertension Clinical Trial

— HYPID  

Official title:
Observational Study of Patients With Pre Capillary Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01443598
Other study ID # GERMOP-002
Secondary ID
Status Completed
Phase N/A
First received September 28, 2011
Last updated June 6, 2016
Start date July 2010
Est. completion date June 2016

Study information
Verified date June 2016
Source Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of Personnes
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 224
Est. completion date June 2016
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Louis Pradel Hospital (Bâtiment A4) Lyon Bron

Sponsors (2)
Lead Sponsor Collaborator
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Determine predictive factors of mortality 2 years No
Secondary Progression-free survival (1) Determine cause of death 2 years No
Secondary Progression-free survival (2) Determine survival and time to worsening 2 years No
Secondary Progression-free survival (3) Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension 2 years No
Secondary Progression-free survival (4) Document the efficacy of PH specific treatment 2 years No
Secondary Progression-free survival (5) Evaluate the level of pulmonary arterial hypertension and compare the functional characteristics of patients with moderate or severe pulmonary hypertension 2 years No
Secondary Progression-free survival (6) Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension 2 years No
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00942708 - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension Phase 2
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1

External Links