Completed

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

What is being collected

Data Collection

Collected from today forward - Prospective

OtherDNA Samples

Who is being recruted

Bone Marrow Diseases+16

+ Cardiovascular Diseases

+ Chronic Disease

From 18 to 95 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: July 2012

See protocol details

Summary

Principal SponsorMedical University of Graz

Last updated: September 9, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01805843

Principal SponsorMedical University of Graz

Last updated: September 9, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 95 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesCardiovascular DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesHypertensionLeukemiaLeukemia, MyeloidLung DiseasesMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsVascular DiseasesDisease AttributesHypertension, PulmonaryLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Criteria

2 inclusion criteria required to participate

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

written informed consent

12 exclusion criteria prevent from participating

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

Hemodynamic relevant valvular disease

Left-sided heart failure or diastolic compliance dysfunction +

Manifest pulmonary hypertension

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical University of Graz, Division of Pulmonology

Graz, AustriaOpen Medical University of Graz, Division of Pulmonology in Google Maps

CompletedOne Study Center