Prevalence of Pulmonary Hypertension (PAH) in Patients With Thalassemia (PAH2010)
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01496963 |
Recruitment Status :
Completed
First Posted : December 22, 2011
Last Update Posted : August 4, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Thalassemia Major Thalassemia Intermedia Pulmonary Arterial Hypertension | Other: Physician standard-of-care according to ESC/ERS Guidelines |

Study Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official 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 |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2021 |
Actual Study Completion Date : | December 2021 |

Group/Cohort | Intervention/treatment |
---|---|
group a)
Patients with pulmonary artery pressure (PAP) assessed (by echocardiogram) <36 mmHg or a tricuspid regurgitant jet velocity (TG) <3 m / sec and data on PAP and mean left ventricular ejection fraction (LVEF) > 50%
|
Other: Physician standard-of-care according to ESC/ERS Guidelines
Physician standard-of-care |
group b)
Patients with: PAP estimated (by echocardiography)> 40 mmHg or TG> 3.2 m / sec and LVEF> 50% As indicated by the Guidelines, patients b) with increased PAP (TG> 3.2 m / sec or> 40 mm Hg) will be further studied using RHC and vasoreactivity testing. Angio CAT, 6MWT and BNP. |
Other: Physician standard-of-care according to ESC/ERS Guidelines
Physician standard-of-care |
group c)
patients with PAP estimated (by echocardiography) in the range of values > 3 m / sec (TG) and <3.2 m / sec or> 36 mm Hg and <40 mmHg and LVEF> 50%
|
Other: Physician standard-of-care according to ESC/ERS Guidelines
Physician standard-of-care |
- Determination of the prevalence [ Time Frame: 12 months ]Determination of the prevalence, defined as the total number of cases in the population, divided by the number of individuals in the population.
- Critical evaluation of current diagnostic criteria [ Time Frame: 12 months ]Critical evaluation of current diagnostic criteria taking into account the peculiarities of the observed of PHA in thalassemic patients.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT01496963
Italy | |
SCDU Microcitemie-Pediatria A.O. Universitaria S.Luigi Gonzaga di Orbassano | |
Orbassano, Turin, Italy, 10043 | |
Divisione di Ematologia Ospedale Perrino | |
Brindisi, Italy, 72100 | |
Clinica pediatrica Ospedale Microcitemico | |
Cagliari, Italy, 09123 | |
DH Microcitemia dell'adulto Ospedale Microcitemico | |
Cagliari, Italy, 09123 | |
Centro della Microcitemia e delle Anemie Congenite -Ematologia e Cardiologia E.O. Ospedali Galliera | |
Genoa, Italy, 16128 | |
Centro Anemie Congenite Università di Milano IRCCS Ospedale Maggiore Policlinico | |
Milan, Italy, 20162 | |
Dipartimento di pediatria "F.Fede" A.O. Universitaria FedericoII di Napoli | |
Napoli, Italy, 80131 | |
U.O.C- Cardiologia Ospedale San Francesco | |
Nuoro, Italy, 8100 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Gian Luca Forni, Principal Investigator and Chief of Centre for Microcythemia an Congenital Anemias - Hematology, Ente Ospedaliero Ospedali Galliera |
ClinicalTrials.gov Identifier: | NCT01496963 |
Other Study ID Numbers: |
PAH2010 |
First Posted: | December 22, 2011 Key Record Dates |
Last Update Posted: | August 4, 2022 |
Last Verified: | August 2022 |
Thalassemia Pulmonary Arterial Hypertension |
Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Thalassemia beta-Thalassemia Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |