Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

Myelodysplastic Syndromes Clinical Trial

Official title:

Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909467
• Other study ID #: 20-097 ex 08/09
• Status: Completed
• Phase: N/A
• First received: May 27, 2009
• Last updated: March 8, 2012
• Start date: April 2009
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Myelodysplastic Syndromes
• Myeloproliferative Disorder
• Myeloproliferative Disorders
• Preleukemia
• Pulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Graz, Pulmonology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean pulmonary arterial pressure at rest and during exercise		at baseline and after 1 year	No
Secondary	exercise capacity		at baseline and after 1 year	No