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Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00909467
First received: May 27, 2009
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these conditions is not known. The effects of pulmonary hypertension on the clinical picture and the symptoms of patients in these conditions needs also further exploration. This exploratory study is designed to describe the prevalence of pulmonary hypertension in the population with such hematologic diseases, and the stages of pulmonary hypertension as well its effect on exercise capacity at time of diagnosis.


Condition Intervention
Myeloproliferative Disorder
Myelodysplastic Syndromes
Pulmonary Hypertension
 Other: echocardiography, right heart catheterisation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • mean pulmonary arterial pressure at rest and during exercise [ Time Frame: at baseline and after 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • exercise capacity [ Time Frame: at baseline and after 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples with DNA will be retained for later examinations at the Department for Genetics, if the patient agrees with it (specific question at the patient information).


Enrollment: 86
Study Start Date: April 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
myeloproliferative, -dysplastic disease Other: echocardiography, right heart catheterisation
at each patient an echocardiography will be performed at rest and during exercise. For the evaluation of exercise capacity, cardiopulmonary exercise testing and six-minute walk is performed. Right heart catheterisation is recommended to those with suspected pulmonary hypertension.
Other Name: EDE, RHC

Detailed Description:

For early recognition of pulmonary hypertension exercise doppler echocardiography will be used in all patients. Patients with elevated pulmonary arterial pressure at rest or during exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential sign of pulmonary hypertension) are advised to undergo right heart catheterisation. Cardiopulmonary exercise testing and six-minute walk distance measurement are performed to measure exercise capacity. The described work-up of patients allows precise and objective hemodynamic and clinical evaluation.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with known myeloproliferative or myelodysplastic disease as a risk factor for pulmonary hypertension

Criteria

Inclusion Criteria:

  • myelodysplastic disease or myeloproliferative diseases

Exclusion Criteria:

  • known pulmonary hypertension
  • relevant pulmonary disease
  • relevant left cardiac or valvular disease
  • recent major operations
  • recent changes in medications
  • relevant anaemia
  • inability to exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909467

Locations
Austria
Medical University of Graz, Pulmonology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz, Pulmonology
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT00909467     History of Changes
Other Study ID Numbers: 20-097 ex 08/09
Study First Received: May 27, 2009
Last Updated: March 8, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Lung Diseases
Respiratory Tract Diseases
 Vascular Diseases
Cardiovascular Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013