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Pulmonary Vascular Changes in Patients With Chronic Myeloid Leukemia With Second-line Therapy Dasatinib vs. Nilotinib

18 Years
95 Years
Open (Enrolling)
Chronic Myeloid Leukemia

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Trial Information

Pulmonary Vascular Changes in Patients With Chronic Myeloid Leukemia With Second-line Therapy Dasatinib vs. Nilotinib

Doppler echocardiography at rest will be performed in each patient. Patients without
exercise capacity limitation an exercise test (Doppler echocardiography with spiroergometry)
will be performed. Patients who show elevated SPAP at rest or during exercise (in this study
SPAP ≥ 40 mmHg) or with reduced exercise capacity (peak VO2 < 75%) a right heart
catheterization (RHC) will be suggested. Additionally for the evaluation of exercise
capacity a 6 MWD will be performed. This work- up of patients allows clinical and
hemodynamic evaluation.

Inclusion Criteria:

- patients with chronic myeloid leukemia under second-line therapy with dasatinib or

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

systolic pulmonary arterial pressure during exercise (50W)

Outcome Description:

In patients who undergo stressechocardiography: systolic pulmonary arterial pressure (SPAP) at 50W will be measured and the comparison between patients under dasatinib and nilotinib therapy will be performed.

Outcome Time Frame:

at baseline

Safety Issue:


Principal Investigator

Horst Olschewski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Graz


Austria: Federal Office for Safety in Health Care

Study ID:

24-311 ex 10/11



Start Date:

July 2012

Completion Date:

July 2013

Related Keywords:

  • Chronic Myeloid Leukemia
  • Pulmonary hypertension
  • chronic myeloid leukemia
  • dasatinib
  • nilotinib
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive