Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

Pulmonary Hypertension Clinical Trial

Official title:

Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787162
• Other study ID #: 24-393 ex 11/12
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: September 7, 2015
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• 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

Goal of the study is to assess the frequency of pulmonary hypertension in patients with chronic myeloproliferative diseases. In each patient an echocardiography at rest will be performed. In patients without musculoskeletal disease an exercise test (spiroergometry) will be performed. Patients with elevated SPAP at rest or with reduced exercise capacity (peak VO2 < 65%) a right heart catheterization (RHC) will be recommended. Also patients with advanced NYHA functional class (III or IV) or with typical PH findings in electrocardiogram will be advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6 MWD will be performed.

This work- up of patients allows clinical and hemodynamic evaluation.

Description:

Previous small studies and clinical cases have suggested a possible association between pulmonary hypertension (PH) and chronic myeloproliferative disorders (CMPD). MPD may cause PH through different mechanisms as: high cardiac output, asplenia, direct obstruction of pulmonary arteries by megakaryocytes, chronic thromboembolic endothelial pulmonary hypertension (CTEPH), porto-pulmonary hypertension (POPH). However, the exact prevalence of PH in this group of disorders is not known.

This study is designed to identify the pulmonary vascular changes and describe the prevalence of pulmonary hypertension (defined in this study as mean pulmonary arterial hypertension (mPAP) ≥25mmHg as assessed by right-heart catheterization (RHC) or systolic pulmonary arterial pressure (sPAP) ≥37mmHg (2.9 m/s) assessed by echocardiography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patients with myeloproliferative disorders

• Written informed consent

Exclusion Criteria:

• Manifest pulmonary hypertension

• Significant pulmonary disease

• Left-sided heart failure or diastolic compliance dysfunction

• Hemodynamic relevant valvular disease

• Systemic arterial hypertension (at rest systolic >150 mmHg, diastolic > 90 mmHg, during exercise > 220 mmHg)

• Severe anemia

• Uncontrolled supraventricular and ventricular arrhythmias

• Myocardial infarction (within the last 12 months)

• Pulmonary embolism (within the last 12 months)

• Recent therapy changes (within the last 12 months)

• Recent major surgeries (within the last 12 months)

• For exercise tests: musculoskeletal diseases which may unable the exercise tests

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Myeloproliferative Disorders
• Pulmonary Hypertension

Intervention

Other:
• Echocardiography, spiroergometry, cardiac catheterization
patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated

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	pulmonary arterial pressure		at baseline	No
Secondary	change of pulmonary arterial pressure		between baseline and after 6 months	No