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NCT Number: NCT03751410

Chronic Ibrutinib Therapy Effect on Left Atrial Function

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.

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Key information

Conditions

Atrium; Beat Echocardiography Physiology Therapy Adverse Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sestre milosrdnice University Hospital

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with haemato-oncologic diseases (including chronic lymphocytic leukemia, Mantle-cell lymphoma, Waldenstrom macroglobulinaemia, etc.)
  • patients prescribed with chronic ibrutinib therapy
  • patients who are able to understand and sign informed consent

Exclusion criteria

  • patients with haemato-oncologic diseases who were prescribed with concomitant chemotherapy which can impact left atrial function
  • patients < 18 years old
  • patients with known or at initial echocardiography established dilated cardiomyopathy with left ventricular ejection fraction < 35%
  • patients with permanent atrial fibrillation and dilated left atrium or dilated both atriums
  • patients implanted with cardiac implantable electronic devices
  • patients who underwent cardiac surgery
  • patients with congenital heart diseases (surgically corrected or not)
  • patients with severe valvular pathology
  • patients with terminal renal disease
  • patients with chronic obstructive pulmonary disease - GOLD grade 4
  • patients with life expectancy < 12 months
  • patients not willing to undergo clinical follow-up or sign informed consent
  • patients recruited in another clinical study

Treatment and study plan

Primary outcomes

  1. left atrial function change

    Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy

    change of the left atrial function measured by the decrease of the left atrial strain deformation > 10% assessed by transthoracic echocardiography

Secondary outcomes

  1. left ventricular ejection fraction change

    Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy

    measurement of left ventricular systolic function change assessed by transthoracic echocardiography - method according to Simpson and Teicholz

  2. left ventricular diastolic function change

    Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy

    measurement of left ventricular diastolic function change assessed by transthoracic echocardiography (E/A and E/E')

  3. left atrial volume change

    Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy

    2D and 3D left atrial volume change assessed by transthoracic echocardiography + left atrial dimension in PLAX and 4 chamber projection

  4. P wave duration change

    Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy

    P wave duration and PQ interval duration change assessed in 12-lead electrocardiogram (in milliseconds)

  5. left atrial pump function change

    Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy

    left atrial ejection fractionchange assessed by transthoracic echocardiography (doppler strain measurement method)

  6. atrial fibrillation incidence

    Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy

    incidence of paroxysmal atrial fibrillation assessed by symptoms + ECG or 24-hours Holter-ECG

Sponsors and collaborators

Lead sponsor

University Hospital Sestre Milosrdnice

Other

Registry information

Official study title

Long-term Effect of Chronic Ibrutinib Therapy on Left Atrial Function

Acronym: CITE-LA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2018
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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