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Trial record 4 of 617 for:    PAH

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Dr. Gian Luca Forni, Ente Ospedaliero Ospedali Galliera.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496963
First Posted: December 22, 2011
Last Update Posted: August 5, 2015
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.
Information provided by (Responsible Party):
Dr. Gian Luca Forni, Ente Ospedaliero Ospedali Galliera
  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:


Further study details as provided by Dr. Gian Luca Forni, Ente Ospedaliero Ospedali Galliera:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1500
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Publications:
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     History of Changes
Other Study ID Numbers: PAH2010
First Submitted: December 14, 2011
First Posted: December 22, 2011
Last Update Posted: August 5, 2015
Last Verified: August 2015

Keywords provided by Dr. Gian Luca Forni, Ente Ospedaliero Ospedali Galliera:
Thalassemia
Pulmonary Arterial Hypertension

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