Chronic Ibrutinib Therapy Effect on Left Atrial Function

কেবল নিবন্ধিত ব্যবহারকারীরা নিবন্ধগুলি অনুবাদ করতে পারবেন

প্রবেশ করুন - নিবন্ধন করুন

লিঙ্কটি ক্লিপবোর্ডে সংরক্ষিত হয়েছে

স্থিতিনিয়োগের

স্পনসর

University Hospital "Sestre Milosrdnice"

ক্লিনিকাল ট্রায়াল: NCT03751410

BioSeek: nct03751410

কীওয়ার্ডস

বিমূর্ত

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.

তারিখ

সর্বশেষ যাচাই করা হয়েছে:	11/30/2018
প্রথম জমা দেওয়া:	11/18/2018
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে:	11/19/2018
প্রথম পোস্ট:	11/22/2018
সর্বশেষ আপডেট জমা দেওয়া হয়েছে:	12/16/2018
সর্বশেষ আপডেট পোস্ট:	12/18/2018
আসল অধ্যয়ন শুরুর তারিখ:	11/30/2018
আনুমানিক প্রাথমিক সমাপ্তির তারিখ:	11/30/2019
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ:	11/30/2020

অবস্থা বা রোগ

Atrium; Beat

Echocardiography

Physiology

Therapy Adverse Effect

পর্যায়

যোগ্যতার মানদণ্ড

বয়স অধ্যয়নের জন্য যোগ্য	18 Years প্রতি 18 Years
লিঙ্গ অধ্যয়নের জন্য যোগ্য	All
নমুনা পদ্ধতি	Non-Probability Sample
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে	হ্যাঁ
নির্ণায়ক	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

ফলাফল

প্রাথমিক ফলাফল ব্যবস্থা

1. left atrial function change [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

মাধ্যমিক ফলাফলের ব্যবস্থা

1. left ventricular ejection fraction change [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 [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 [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 [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 [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 [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

Chronic Ibrutinib Therapy Effect on Left Atrial Function

কীওয়ার্ডস

tyrosine

উদরাময়

hemorrhage

arthralgia

লিউকিমিয়া

lymphoma

atrial fibrillation