Atrium; BeatCITE-LANCT03751410
Chronic Ibrutinib Therapy Effect on Left Atrial Function
An observational study of Atrium; Beat and Echocardiography, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrium; Beat, Echocardiography, Physiology
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Dec 2018to 4 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effect of Chronic Ibrutinib Therapy 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%.
Read more
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.
- Conditions
- Atrium; Beat, Echocardiography, Physiology, Therapy Adverse Effect
- Keywords
- ibrutinib, echocardiography, left atrium, function, long-term
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
Secondary outcomes (6)
left ventricular ejection fraction change
measurement of left ventricular systolic function change assessed by transthoracic echocardiography - method according to Simpson and Teicholz
Measured: 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')
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Dec 2018
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Atrium; BeatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Zeljkovic, University Hospital Sestre Milosrdnice
- Investigators
- Matea Kolacevic, MD, Principal investigator, University Hospital Sestre Milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751410
- Sponsor's protocol ID
- UHS-2
- Other IDs
- U1111-1221-9732
- Acronym
- CITE-LA
- Status last verified
- Oct 2023
- First submitted
- 19 Nov 2018
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deeks ED. Ibrutinib: A Review in Chronic Lymphocytic Leukaemia. Drugs. 2017 Feb;77(2):225-236. doi: 10.1007/s40265-017-0695-3.
PubMed 28105602Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
PubMed 24881631Thompson PA, Burger JA. Bruton's tyrosine kinase inhibitors: first and second generation agents for patients with Chronic Lymphocytic Leukemia (CLL). Expert Opin Investig Drugs. 2018 Jan;27(1):31-42. doi: 10.1080/13543784.2018.1404027. Epub 2017 Nov 15.
PubMed 29125406Wierda WG, Zelenetz AD, Gordon LI, Abramson JS, Advani RH, Andreadis CB, Bartlett N, Byrd JC, Caimi P, Fayad LE, Fisher RI, Glenn MJ, Habermann TM, Harris NL, Hernandez-Ilizaliturri F, Hoppe RT, Horwitz SM, Kaminski MS, Kelsey CR, Kim YH, Krivacic S, LaCasce AS, Martin MG, Nademanee A, Porcu P, Press O, Rabinovitch R, Reddy N, Reid E, Roberts K, Saad AA, Snyder ED, Sokol L, Swinnen LJ, Vose JM, Yahalom J, Dwyer MA, Sundar H. NCCN Guidelines Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 1.2017. J Natl Compr Canc Netw. 2017 Mar;15(3):293-311. doi: 10.6004/jnccn.2017.0030.
PubMed 28275031Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.
PubMed 26639149Kaur V, Swami A. Ibrutinib in CLL: a focus on adverse events, resistance, and novel approaches beyond ibrutinib. Ann Hematol. 2017 Jul;96(7):1175-1184. doi: 10.1007/s00277-017-2973-2. Epub 2017 Mar 24.
PubMed 28342031O'Brien S, Hillmen P, Coutre S, Barr PM, Fraser G, Tedeschi A, Burger JA, Dilhuydy MS, Hess G, Moreno C, Cramer P, Liu E, Chang S, Vermeulen J, Styles L, Howes A, James DF, Patel K, Graef T, Valentino R. Safety Analysis of Four Randomized Controlled Studies of Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Mantle Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):648-657.e15. doi: 10.1016/j.clml.2018.06.016. Epub 2018 Jun 28.
PubMed 30061088Reda G, Fattizzo B, Cassin R, Mattiello V, Tonella T, Giannarelli D, Massari F, Cortelezzi A. Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study. J Hematol Oncol. 2018 Jun 11;11(1):79. doi: 10.1186/s13045-018-0626-0.
PubMed 29891001Boriani G, Corradini P, Cuneo A, Falanga A, Foa R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, Zinzani PL. Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding. Hematol Oncol. 2018 Oct;36(4):624-632. doi: 10.1002/hon.2503. Epub 2018 Mar 7.
PubMed 29512173Mato AR, Clasen S, Pickens P, Gashonia L, Rhodes J, Svoboda J, Hughes M, Nabhan C, Ali N, Schuster S, Carver J. Left atrial abnormality (LAA) as a predictor of ibrutinib-associated atrial fibrillation in patients with chronic lymphocytic leukemia. Cancer Biol Ther. 2018 Jan 2;19(1):1-2. doi: 10.1080/15384047.2017.1394554. Epub 2017 Dec 27.
PubMed 29281559Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. doi: 10.1182/blood-2016-05-712828. Epub 2016 May 31. No abstract available.
PubMed 27247135Kolacevic Zeljkovic M, Basic-Kinda S, Carzavec D, Vodanovic M, Mandac Smoljanovic I, Jaksic O, Novak M, Ostojic-Kolonic S, Dujmovic D, Pejsa V, Aurer I, Bulj N. Longitudinal changes in left atrial function during chronic ibrutinib therapy: a prospective observational study. Front Cardiovasc Med. 2026 Aug 26;13:1914493. doi: 10.3389/fcvm.2026.1914493. eCollection 2026.
PubMed 42718685
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Chronic Ibrutinib Therapy on Left Atrial Function
- ClinicalTrials.gov ID
- NCT03751410
- Acronym / sponsor ID
- CITE-LA / UHS-2
- Conditions
- Atrium; Beat, Echocardiography, Physiology, Therapy Adverse Effect
- Keywords
- ibrutinib, echocardiography, left atrium, function, long-term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
left ventricular ejection fraction change
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
left ventricular diastolic function change
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
left atrial volume change
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
P wave duration change
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
left atrial pump function change
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
atrial fibrillation incidence
Time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Results publication: PubMed 28105602Deeks ED. Ibrutinib: A Review in Chronic Lymphocytic Leukaemia. Drugs. 2017 Feb;77(2):225-236. doi: 10.1007/s40265-017-0695-3.
- Results publication: PubMed 24881631Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
- Results publication: PubMed 29125406Thompson PA, Burger JA. Bruton's tyrosine kinase inhibitors: first and second generation agents for patients with Chronic Lymphocytic Leukemia (CLL). Expert Opin Investig Drugs. 2018 Jan;27(1):31-42. doi: 10.1080/13543784.2018.1404027. Epub 2017 Nov 15.
- Results publication: PubMed 28275031Wierda WG, Zelenetz AD, Gordon LI, Abramson JS, Advani RH, Andreadis CB, Bartlett N, Byrd JC, Caimi P, Fayad LE, Fisher RI, Glenn MJ, Habermann TM, Harris NL, Hernandez-Ilizaliturri F, Hoppe RT, Horwitz SM, Kaminski MS, Kelsey CR, Kim YH, Krivacic S, LaCasce AS, Martin MG, Nademanee A, Porcu P, Press O, Rabinovitch R, Reddy N, Reid E, Roberts K, Saad AA, Snyder ED, Sokol L, Swinnen LJ, Vose JM, Yahalom J, Dwyer MA, Sundar H. NCCN Guidelines Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 1.2017. J Natl Compr Canc Netw. 2017 Mar;15(3):293-311. doi: 10.6004/jnccn.2017.0030.
- Results publication: PubMed 26639149Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.
- Results publication: PubMed 28342031Kaur V, Swami A. Ibrutinib in CLL: a focus on adverse events, resistance, and novel approaches beyond ibrutinib. Ann Hematol. 2017 Jul;96(7):1175-1184. doi: 10.1007/s00277-017-2973-2. Epub 2017 Mar 24.
- Results publication: PubMed 30061088O'Brien S, Hillmen P, Coutre S, Barr PM, Fraser G, Tedeschi A, Burger JA, Dilhuydy MS, Hess G, Moreno C, Cramer P, Liu E, Chang S, Vermeulen J, Styles L, Howes A, James DF, Patel K, Graef T, Valentino R. Safety Analysis of Four Randomized Controlled Studies of Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Mantle Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):648-657.e15. doi: 10.1016/j.clml.2018.06.016. Epub 2018 Jun 28.
- Results publication: PubMed 29891001Reda G, Fattizzo B, Cassin R, Mattiello V, Tonella T, Giannarelli D, Massari F, Cortelezzi A. Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study. J Hematol Oncol. 2018 Jun 11;11(1):79. doi: 10.1186/s13045-018-0626-0.
- Results publication: PubMed 29512173Boriani G, Corradini P, Cuneo A, Falanga A, Foa R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, Zinzani PL. Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding. Hematol Oncol. 2018 Oct;36(4):624-632. doi: 10.1002/hon.2503. Epub 2018 Mar 7.
- Results publication: PubMed 29281559Mato AR, Clasen S, Pickens P, Gashonia L, Rhodes J, Svoboda J, Hughes M, Nabhan C, Ali N, Schuster S, Carver J. Left atrial abnormality (LAA) as a predictor of ibrutinib-associated atrial fibrillation in patients with chronic lymphocytic leukemia. Cancer Biol Ther. 2018 Jan 2;19(1):1-2. doi: 10.1080/15384047.2017.1394554. Epub 2017 Dec 27.
- Results publication: PubMed 27247135Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. doi: 10.1182/blood-2016-05-712828. Epub 2016 May 31. No abstract available.
- Derived from this study: PubMed 42718685Kolacevic Zeljkovic M, Basic-Kinda S, Carzavec D, Vodanovic M, Mandac Smoljanovic I, Jaksic O, Novak M, Ostojic-Kolonic S, Dujmovic D, Pejsa V, Aurer I, Bulj N. Longitudinal changes in left atrial function during chronic ibrutinib therapy: a prospective observational study. Front Cardiovasc Med. 2026 Aug 26;13:1914493. doi: 10.3389/fcvm.2026.1914493. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matea Kolacevic, MD principal investigator
University Hospital Sestre Milosrdnice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrium; Beat and Echocardiography, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left atrial function change (time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751410, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.