Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

NCT00909467 | Completed

• 1 other identifier: 20-097 ex 08/09
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloproliferative Disorder; Myelodysplastic Syndromes; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• mean pulmonary arterial pressure at rest and during exercise

  at baseline and after 1 year

Secondary Outcomes (1)

• exercise capacity

  at baseline and after 1 year

Study Arms (1)

myeloproliferative, -dysplastic disease

Other: echocardiography, right heart catheterisation

Interventions

echocardiography, right heart catheterisation 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.

Also known as: EDE, RHC

myeloproliferative, -dysplastic disease

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• myelodysplastic disease or myeloproliferative diseases

You may not qualify if:

• known pulmonary hypertension
• relevant pulmonary disease
• relevant left cardiac or valvular disease
• recent major operations
• recent changes in medications
• relevant anaemia
• inability to exercise

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz, Pulmonology

Graz, 8036, Austria

Location

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).

MeSH Terms

Conditions

Myeloproliferative Disorders; Myelodysplastic Syndromes; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Horst Olschewski, MD

  Medical University of Graz, Pulmonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

AU (1)