An observational study in Atrium; Beat, Echocardiography and Physiology, sponsored by University Hospital Sestre Milosrdnice. Completed at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by University Hospital Sestre Milosrdnice · Observational
Ibrutinib is an irreversible Bruton tyrosine-kinase inhibitor. In prospective studies, the ibrutinib efficacy in the treatment of various B-cell malignancies was established. Different ibrutinib side-effects have been found: diarrhea, arthralgia, infections, neutropenia, hypertension and increased risk of bleeding. Most of the mentioned side-effects were \<3rd degree of severity and mostly didn't require dose adjustment or therapy discontinuation. Also, there was an increase in the incidence of atrial fibrillation (AFib) (6-16%). The AFib pathogenesis in this patient population is not clarified, but there are indications that ibrutinib inhibits phosphoinositide-3-kinase (PI3K)-Akt signal-pathway expressed in the myocytes. Regardless of the molecular pathogenesis, the clinical effect of ibrutinib on the myocardium, especially the left atrium, has not been studied. Hence, the aim of this study is to determine the ibrutinib effect on echocardiographic parameters of left atrial function.
This study will be performed as a clinical, prospective, observational cohort study with a structured follow-up period of 12 months. All consecutive patients with hemato-oncologic diseases (including chronic lymphocytic leukemia, Mantle-cell lymphoma, Waldenstrom macroglobulinemia, etc.) prescribed with chronic ibrutinib therapy, who are able to understand and sign informed consent, will be enrolled. Primary objective is change of the left atrial function measured by the decrease of the left atrial strain deformation > 10%.
Recruiting should not exceed 12 months with the minimal follow-up period of 12 months (24 months in total). Standardized statistical methods and tests will be done using SPSS Version 22.0 or newer.
This unique study offers the possibility to show the long-term effect of chronic ibrutinib therapy on left atrial function assessed by transthoracic echocardiography. This observational data is needed to further refine the treatment of these patients and to prevent possible side-effects of ibrutinib which could endanger this specific patient population.
University Hospital Sestre Milosrdnice is the lead sponsor of 27 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients with haemato-oncologic diseases (including chronic lymphocytic leukemia, Mantle-cell lymphoma, Waldenstrom macroglobulinaemia) prescribed with chronic ibrutinib therapy, who are able to understand and sign informed consent, will be enrolled.
Exclusion Criteria:
left atrial function change
change of the left atrial function measured by the decrease of the left atrial strain deformation \> 10% assessed by transthoracic echocardiography
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
left ventricular ejection fraction change
measurement of left ventricular systolic function change assessed by transthoracic echocardiography - method according to Simpson and Teicholz
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
left ventricular diastolic function change
measurement of left ventricular diastolic function change assessed by transthoracic echocardiography (E/A and E/E')
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
left atrial volume change
2D and 3D left atrial volume change assessed by transthoracic echocardiography + left atrial dimension in PLAX and 4 chamber projection
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
P wave duration change
P wave duration and PQ interval duration change assessed in 12-lead electrocardiogram (in milliseconds)
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
left atrial pump function change
left atrial ejection fractionchange assessed by transthoracic echocardiography (doppler strain measurement method)
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
atrial fibrillation incidence
incidence of paroxysmal atrial fibrillation assessed by symptoms + ECG or 24-hours Holter-ECG
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University Hospital Sestre Milosrdnice