Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

• Sponsor: Medical University of Graz (Other)
• Overall Status: Completed
• CT.gov ID: NCT00909467
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Duration (Months): 31
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloproliferative Disorder; Myelodysplastic Syndromes; Pulmonary Hypertension	Other: echocardiography, right heart catheterisation

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: EDE, RHC

Outcome Measures

Primary Outcome Measures

1. mean pulmonary arterial pressure at rest and during exercise [at baseline and after 1 year]

Secondary Outcome Measures

1. exercise capacity [at baseline and after 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT00909467
• Other Study ID Numbers: 20-097 ex 08/09
• First Posted: May 28, 2009
• Last Update Posted: Mar 9, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Myelodysplastic Syndromes; Myeloproliferative Disorders

Study Results

No Results Posted as of Mar 9, 2012