Pulmonary Arterial Hypertension Clinical Trial
— PAH2010Official title:
Observational Multicenter Study Lasting 12 Months to Determine the Prevalence of Pulmonary Hypertension (PAH) in Patients With Thalassemia Major and Intermedia and Verify the Suitability of Common Diagnostic Criteria in This Population
NCT number | NCT01496963 |
Other study ID # | PAH2010 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | December 2021 |
Verified date | August 2022 |
Source | Ente Ospedaliero Ospedali Galliera |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a multicenter observational case-control analysis lasting 12 months aimed at determining the prevalence of pulmonary hypertension (PAH) in patients with Thalassemia Major and Intermedia. The patients will be followed, treated and examined according to the best standard clinical practice dictated by the Italian Society for the study of Hemoglobinopathies (SITE), Thalassemia International Federation (TIF)and the Task Force for Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC); European Respiratory Society (ERS); International Society of Heart and Lung Transplantation (ISHLT) guidelines.
Status | Completed |
Enrollment | 1500 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with Thalassemia Major Patients or Intermediate referring to Centres using Web-Thal medical record (a clinical data sheet used for congenital anemias. Info: www.thalassemia.it) Exclusion Criteria: - Patients who are considered potentially unreliable and/or not cooperative |
Country | Name | City | State |
---|---|---|---|
Italy | Divisione di Ematologia Ospedale Perrino | Brindisi | |
Italy | Clinica pediatrica Ospedale Microcitemico | Cagliari | |
Italy | DH Microcitemia dell'adulto Ospedale Microcitemico | Cagliari | |
Italy | Centro della Microcitemia e delle Anemie Congenite -Ematologia e Cardiologia E.O. Ospedali Galliera | Genoa | |
Italy | Centro Anemie Congenite Università di Milano IRCCS Ospedale Maggiore Policlinico | Milan | |
Italy | Dipartimento di pediatria "F.Fede" A.O. Universitaria FedericoII di Napoli | Napoli | |
Italy | U.O.C- Cardiologia Ospedale San Francesco | Nuoro | |
Italy | SCDU Microcitemie-Pediatria A.O. Universitaria S.Luigi Gonzaga di Orbassano | Orbassano | Turin |
Lead Sponsor | Collaborator |
---|---|
Ente Ospedaliero Ospedali Galliera |
Italy,
Task Force for Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC); European Respiratory Society (ERS); International Society of Heart and Lung Transplantation (ISHLT), Galiè N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34(6):1219-63. doi: 10.1183/09031936.00139009. Epub 2009 Sep 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of the prevalence | Determination of the prevalence, defined as the total number of cases in the population, divided by the number of individuals in the population. | 12 months | |
Secondary | Critical evaluation of current diagnostic criteria | Critical evaluation of current diagnostic criteria taking into account the peculiarities of the observed of PHA in thalassemic patients. | 12 months |
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 | |
Withdrawn |
NCT01723371 -
Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT01649739 -
Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
|
Phase 4 | |
Unknown status |
NCT01712997 -
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
|
Phase 3 | |
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 |
NCT00963001 -
Effect of Food on the Pharmacokinetics of Oral Treprostinil
|
Phase 1 | |
Completed |
NCT00902174 -
Imatinib (QTI571) in Pulmonary Arterial Hypertension
|
Phase 3 |