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Prevalence of Pulmonary Hypertension (PAH) in Patients With Thalassemia (PAH2010)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Gian Luca Forni, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier:
NCT01496963
First received: December 14, 2011
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Thalassemia Major
Thalassemia Intermedia
Pulmonary Arterial Hypertension
 Other: Physician standard-of-care according to ESC/ERS Guidelines

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ente Ospedaliero Ospedali Galliera:

Primary Outcome Measures:
  • Determination of the prevalence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determination of the prevalence, defined as the total number of cases in the population, divided by the number of individuals in the population.


Secondary Outcome Measures:
  • Critical evaluation of current diagnostic criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Critical evaluation of current diagnostic criteria taking into account the peculiarities of the observed of PHA in thalassemic patients.


Estimated Enrollment: 1500
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Thalassemia Major and Intermedia studied by echocardiography in the six months prior to the beginning of the study

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496963

Locations
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
Sponsors and Collaborators
Ente Ospedaliero Ospedali Galliera
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: PAH2010
Study First Received: December 14, 2011
Last Updated: June 27, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Ente Ospedaliero Ospedali Galliera:
Thalassemia
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Beta-Thalassemia
Hypertension, Pulmonary
Hypertension
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013