Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

NCT ID: NCT00909467

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-11-30

Brief Summary

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.

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.

Conditions

Myeloproliferative Disorder; Myelodysplastic Syndromes; Pulmonary Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

myeloproliferative, -dysplastic disease

echocardiography, right heart catheterisation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

EDE, RHC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Horst Olschewski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Pulmonology

Locations

Medical University of Graz, Pulmonology

Graz, , Austria

Countries

Austria

Other Identifiers

20-097 ex 08/09

Identifier Type: -

Identifier Source: org_study_id