HemodialysisFibCA-HDNCT06668831
Fibroblast Growth Factor 23 and Risk of Cardiac Arrhythmias in Hemodialysis Patients
An observational study of Hemodialysis, run by Antonio Bellasi at 1 site in Switzerland.
Trial summary
Despite recent progress in the field of hemodialysis (HD), mortality remains unacceptably high, particularly due to cardiac arrhythmias. Recent evidence suggests that fibroblast growth factor 23 (FGF23) is implicated in the pathogenesis of cardiac arrhythmias and sudden death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Oct 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult subjects on maintenance hemodialysis
Who may be able to join
None listed.
Who cannot join
- history of cardiac arrhythmias at study recruitment define as atrial fibrillation or pace-maker assisted cardiac rhythm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Servizio di Nefrologia, Ospedale Regionale di Lugano, Civico
Lugano, CH-6903
Davide Salera, MD, +410918116166, davide.salera@eoc.ch
antonio bellasi, MD, PhD
About this study
Official title: Fibroblast Growth Factor 23 and Risk of Cardiac Arrhythmias in Hemodialysis Patients: a Proof-of-concept Study (FibCa-HD)
Despite recent progress in the field of hemodialysis (HD), mortality remains unacceptably high, particularly due to cardiac arrhythmias. Recent evidence suggests that fibroblast growth factor 23 (FGF23) is implicated in the pathogenesis of cardiac arrhythmias and sudden death. However, several aspects of both the pathogenetic mechanism(s) as well as the actual association in individuals with Chronic Kidney Disease (CKD) and the effect of dialysis clearance of FGF23 need to be elucidated.
The investigators aim at testing the independent association of FGF23 changes due to dialysis removal and electrocardiographic (ECG) abnormalities (namely QTc prolongation) in a well characterized sample of patients undergoing maintenance HD. The study will be developed in the Division of Nephrology, Ente Ospedaliero Cantonale.
Read the detailed description
This is an exploratory, observational, prospective, mono-center study that aims to elucidate the pathogenesis of cardiac repolarization and arrhythmias in subjects with CKD receiving maintenance dialysis.
This exploratory research project aims to confirm the link between FGF23 and ECG abnormalities (QTc as a proxy for cardiac arrhythmias) in a well-characterized sample of HD patients and expand our understanding of the molecular mechanisms by which FGF23 may trigger arrhythmias.
Previous works suggest that FGF23 cardiac toxicity may be mediated by the activation of FGFR4 and that modulation of FGF23-FGFR4 signaling through monoclonal antibodies can attenuate the toxic effects of FGF23 on the CM. Although these preliminary data warrant clinical and molecular confirmation, they also suggest FGF23-FGFR4 modulation as a novel potential therapeutic target in CKD to improve morbidity and mortality.
During a standard dialysis session, FGF23 is acutely removed while Ca2+ is provided to the patients. However, shortly after the HD session completion, it was documented that FGF23 serum levels rebound. The investigators hypothesize that acute reduction and subsequent rebound of circulatory levels of FGF23 coupled with calcium loading induced by HD may favour a Ca 2+ influx in the CM and trigger cardiac arrhythmias.
This exploratory study aims to determine the independent association between variations in serum levels of FGF23 and QTc (msec) during and after dialysis. In particular, the primary endpoint of the study is defined as the association between QTc variations (msec) defined as the difference between QTc pre-dialysis and QTc 1 hour after dialysis session completion and variations of serum levels of FGF23 defined as the difference between serum levels of FGF23 at dialysis session completion and after 1-hour form dialysis session completion. The investigators hypothesize that these time points should maximize the chance of detecting a significant association between the exposure variable (FGF23) and the outcome of interest (QTc).
All study procedures are non-invasive, and they will be carried out between the beginning of the last HD of the week and the beginning of the first HD of the following week (long interdialytic interval) to allow for the maximum variation of serum levels of FGF23 between dialysis sessions.
All study-related procedures are performed on top of standard clinical practice, and guidelines are performed non-invasively. Study participants will undergo the following procedures:
- ECG: A standard 12-leads ECG will be recorded at the beginning, at the end as well as 60 minutes after the end of the last HD session of the week and at the beginning of the first HD session of the following week. All readings will be performed will be centralized and read by a single investigator blinded to clinical information at EOC.
- Laboratory assessment: a blood sample will be taken at the beginning, at the end, and 60 minutes after the end of the last HD session of the week and at the beginning of the first HD session of the following week. Laboratory investigations will check the serum values of cardiovascular biomarkers (including FGF23) associated with QTc and volume expansion (OH: overhydration). Venous blood samples for measurement of cardiovascular biomarkers will be drawn at each time point and stored in the biobank at Ente Ospedaliero Cantonale (EOC) according to the standard procedures. These aliquotes will be used to assess FGF23 and for subsequent in-vitro evaluation of the cardiac arrhythmogenicity of patients' sera in relation to the homeostasis variation induced by HD.
- Volume assessment: total body weight will be measured at dialysis session, to calculate the net body weight increase during the long interval. Overhydration (OH) will be quantitatively assessed with a portable whole-body bioimpedance spectroscopy device (Fresenius Medical Care GmbH, Bad Homburg, Germany). The total body water (TBW), the extracellular water (ECW), the intracellular water (ICW), and the OH are calculated as previously defined
- Applanation tonometry: Central blood pressure (BP) values and aortic pressure waveforms will be obtained non-invasively directly from the common carotid artery using a validated high fidelity PulsePen tonometer (DiaTecne, San Donato Milanese, Italy). In particular, the subendocardial viability ratio (SEVR) will be calculated during the first HD session of the week according to the central BP wave form as previously reported
- Echocardiogram: If no echocardiogram exam within 12 months from study inception is available in the patient's chart, a two-dimensional echocardiographic study will be performed before the first HD session of the week utilizing a standard equipment as per standard clinical practice. Digital images will be acquired in the long axis and short axis parasternal views and the apical four and two chamber views and three-cycle clips will be stored on magnetic optical disks for future review. The presence of valvular calcification (aortic and mitral valve) as well as systolic and diastolic function assessment will be performed.
Adverse event: The occurrence of any adverse events (AE) will be recorded for the occurrence of any event from study inception until the end of the following week This exploratory study will be carried out at the Division of Nephrology, Ente Ospedaliero Cantonale (EOC), Ticino, Switzerland.
- Conditions
- Hemodialysis
- Keywords
- fgf23, cardiac arrhythmia, QTc, cardiovascular risk
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects on maintenance hemodialysis | The study envisages the enrolment of: * adult subjects (>18 years of age) who are able to sign an informed consent. * on maintenance HD (for at least 3 months) * without history of cardiac arrhythmias at study recruitment define as atrial fibrillation or pace-maker assisted cardiac rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations of QTc and FGF23 changes
The primary endpoint of the study is defined as the association between QTc variations (msec) defined as a continuous variable as the difference between QTc pre-dialysis and QTc 1 hour after dialysis session completion and variations of serum levels of FGF23 defined as a continuous variable as the difference between serum levels of FGF23 at dialysis session completion and after 1-hour form dialysis session completion. We hypothesize that these time points should maximize the chance of detecting a significant association between the exposure variable (FGF23) and the outcome of interest (QTc).
Measured: the primary endpoint will be assessed one hour after dialysis cessation
Secondary outcomes (2)
To gauge the dynamic association between FGF23 and QTc we will also explore
- Association of serum levels of FGF23 and QTc (msec) at dialysis session initiation (both utilized as continuous variables) B. Association of serum levels of FGF23 and QTc (msec) at dialysis session completion C. Association of serum levels of FGF23 and QTc (msec) 1 hour after dialysis session completion D. Association of QTc variations (msec - defined as the difference between QTc pre-dialysis and QTc after dialysis session completion) and serum levels of FGF23 variations before and after dialysis session completion (defined as the difference between serum levels of FGF23 at dialysis session initiation and dialysis session completion) E. Association of QTc variations (msec - defined as the difference between QTc at dialysis session completion and QTc 1 hour after dialysis session completion) and serum levels of FGF23 variations before and 1 hour after dialysis session completion (defined as variable as the difference between serum levels of FGF23 at dialysis session completion)
Measured: these endpoints will be assessed between dialysis session initiation and 1 hour after dialysis session cessation
To gauge the dynamic association between FGF23 and QTc we will also explore
- Association of QTc variations (msec - defined as the difference between QTc at dialysis session completion and QTc 72 hours after dialysis session completion) and serum levels of FGF23 variations before and after 72 hours from dialysis session completion (defined as the difference between serum levels of FGF23 at dialysis session completion and 72 hours after dialysis session completion).
- Association of serum levels of FGF23 and QTc (msec) at the beginning of the first dialysis of the week, after the long interdialytic interval.
Measured: These endpoints will be assessed bewteen the beginning of the last dialysis of the week and the beginning of the first dialysis of the following week (72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start12 Oct 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Bellasi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Bellasi, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Antonio Bellasi, MD, PhD, Principal investigator, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668831
- Sponsor's protocol ID
- FibCA-HD
- Acronym
- FibCA-HD
- Status last verified
- Jul 2025
- First submitted
- 30 Oct 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD maybe shared upon request and in respect with the regulation on data protection
Publications
Arrigo M, Von Moos S, Gerritsen K, Sadoune M, Tangvoraphonkchai K, Davenport A, Mebazaa A, Segerer S, Cippa PE. Soluble CD146 and B-type natriuretic peptide dissect overhydration into functional components of prognostic relevance in haemodialysis patients. Nephrol Dial Transplant. 2018 Nov 1;33(11):2035-2042. doi: 10.1093/ndt/gfy113.
PubMed 29733422Tiong MK, Krishnasamy R, Smith ER, Hutchison CA, Ryan EG, Pascoe EM, Hawley CM, Hewitson TD, Jardine MJ, Roberts MA, Cho Y, Wong MG, Heath A, Nelson CL, Sen S, Mount PF, Vergara LA, Paul-Brent PA, Johnson DW, Toussaint ND. Effect of a medium cut-off dialyzer on protein-bound uremic toxins and mineral metabolism markers in patients on hemodialysis. Hemodial Int. 2021 Jul;25(3):322-332. doi: 10.1111/hdi.12924. Epub 2021 Mar 28.
PubMed 33779046Fu X, Cui QQ, Ning JP, Fu SS, Liao XH. High-Flux Hemodialysis Benefits Hemodialysis Patients by Reducing Serum FGF-23 Levels and Reducing Vascular Calcification. Med Sci Monit. 2015 Nov 11;21:3467-73. doi: 10.12659/msm.894894.
PubMed 26558428Sikaneta T, Ho N, Bellasi A, Mahdavi S, Taskapan H, Svendrovski A, Makanjee B, Roberts J, Wu G, Nathoo B, Tam P. QTc Interval Prolongation Is Independently Associated with FGF23 and Predicts Mortality in Predialysis Chronic Kidney Disease. Cardiorenal Med. 2024;14(1):45-57. doi: 10.1159/000535133. Epub 2024 Jan 8.
PubMed 37963445Graves JM, Vallejo JA, Hamill CS, Wang D, Ahuja R, Patel S, Faul C, Wacker MJ. Fibroblast growth factor 23 (FGF23) induces ventricular arrhythmias and prolongs QTc interval in mice in an FGF receptor 4-dependent manner. Am J Physiol Heart Circ Physiol. 2021 Jun 1;320(6):H2283-H2294. doi: 10.1152/ajpheart.00798.2020. Epub 2021 Apr 30.
PubMed 33929896Di Iorio B, Bellasi A. QT interval in CKD and haemodialysis patients. Clin Kidney J. 2013 Apr;6(2):137-43. doi: 10.1093/ckj/sfs183. Epub 2013 Jan 17.
PubMed 26019841Vazquez-Sanchez S, Poveda J, Navarro-Garcia JA, Gonzalez-Lafuente L, Rodriguez-Sanchez E, Ruilope LM, Ruiz-Hurtado G. An Overview of FGF-23 as a Novel Candidate Biomarker of Cardiovascular Risk. Front Physiol. 2021 Mar 9;12:632260. doi: 10.3389/fphys.2021.632260. eCollection 2021.
PubMed 33767635Niu J, Shah MK, Perez JJ, Airy M, Navaneethan SD, Turakhia MP, Chang TI, Winkelmayer WC. Dialysis Modality and Incident Atrial Fibrillation in Older Patients With ESRD. Am J Kidney Dis. 2019 Mar;73(3):324-331. doi: 10.1053/j.ajkd.2018.09.011. Epub 2018 Nov 16.
PubMed 30449517Rantanen JM, Riahi S, Schmidt EB, Johansen MB, Sogaard P, Christensen JH. Arrhythmias in Patients on Maintenance Dialysis: A Cross-sectional Study. Am J Kidney Dis. 2020 Feb;75(2):214-224. doi: 10.1053/j.ajkd.2019.06.012. Epub 2019 Sep 18.
PubMed 31542235Di Lullo L, Rivera R, Barbera V, Bellasi A, Cozzolino M, Russo D, De Pascalis A, Banerjee D, Floccari F, Ronco C. Sudden cardiac death and chronic kidney disease: From pathophysiology to treatment strategies. Int J Cardiol. 2016 Aug 15;217:16-27. doi: 10.1016/j.ijcard.2016.04.170. Epub 2016 May 3.
PubMed 27174593
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroblast Growth Factor 23 and Risk of Cardiac Arrhythmias in Hemodialysis Patients: a Proof-of-concept Study (FibCa-HD)
- ClinicalTrials.gov ID
- NCT06668831
- Acronym / sponsor ID
- FibCA-HD / FibCA-HD
- Conditions
- Hemodialysis
- Keywords
- fgf23, cardiac arrhythmia, QTc, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Antonio BellasiUniversity, hospital or other
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Oct 2024 (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.
Despite recent progress in the field of hemodialysis (HD), mortality remains unacceptably high, particularly due to cardiac arrhythmias. Recent evidence suggests that fibroblast growth factor 23 (FGF23) is implicated in the pathogenesis of cardiac arrhythmias and sudden death. However, several aspects of both the pathogenetic mechanism(s) as well as the actual association in individuals with Chronic Kidney Disease (CKD) and the effect of dialysis clearance of FGF23 need to be elucidated.
The investigators aim at testing the independent association of FGF23 changes due to dialysis removal and electrocardiographic (ECG) abnormalities (namely QTc prolongation) in a well characterized sample of patients undergoing maintenance HD. The study will be developed in the Division of Nephrology, Ente Ospedaliero Cantonale.
Detailed description
This is an exploratory, observational, prospective, mono-center study that aims to elucidate the pathogenesis of cardiac repolarization and arrhythmias in subjects with CKD receiving maintenance dialysis.
This exploratory research project aims to confirm the link between FGF23 and ECG abnormalities (QTc as a proxy for cardiac arrhythmias) in a well-characterized sample of HD patients and expand our understanding of the molecular mechanisms by which FGF23 may trigger arrhythmias.
Previous works suggest that FGF23 cardiac toxicity may be mediated by the activation of FGFR4 and that modulation of FGF23-FGFR4 signaling through monoclonal antibodies can attenuate the toxic effects of FGF23 on the CM. Although these preliminary data warrant clinical and molecular confirmation, they also suggest FGF23-FGFR4 modulation as a novel potential therapeutic target in CKD to improve morbidity and mortality.
During a standard dialysis session, FGF23 is acutely removed while Ca2+ is provided to the patients. However, shortly after the HD session completion, it was documented that FGF23 serum levels rebound. The investigators hypothesize that acute reduction and subsequent rebound of circulatory levels of FGF23 coupled with calcium loading induced by HD may favour a Ca 2+ influx in the CM and trigger cardiac arrhythmias.
This exploratory study aims to determine the independent association between variations in serum levels of FGF23 and QTc (msec) during and after dialysis. In particular, the primary endpoint of the study is defined as the association between QTc variations (msec) defined as the difference between QTc pre-dialysis and QTc 1 hour after dialysis session completion and variations of serum levels of FGF23 defined as the difference between serum levels of FGF23 at dialysis session completion and after 1-hour form dialysis session completion. The investigators hypothesize that these time points should maximize the chance of detecting a significant association between the exposure variable (FGF23) and the outcome of interest (QTc).
All study procedures are non-invasive, and they will be carried out between the beginning of the last HD of the week and the beginning of the first HD of the following week (long interdialytic interval) to allow for the maximum variation of serum levels of FGF23 between dialysis sessions.
All study-related procedures are performed on top of standard clinical practice, and guidelines are performed non-invasively. Study participants will undergo the following procedures:
- ECG: A standard 12-leads ECG will be recorded at the beginning, at the end as well as 60 minutes after the end of the last HD session of the week and at the beginning of the first HD session of the following week. All readings will be performed will be centralized and read by a single investigator blinded to clinical information at EOC.
- Laboratory assessment: a blood sample will be taken at the beginning, at the end, and 60 minutes after the end of the last HD session of the week and at the beginning of the first HD session of the following week. Laboratory investigations will check the serum values of cardiovascular biomarkers (including FGF23) associated with QTc and volume expansion (OH: overhydration). Venous blood samples for measurement of cardiovascular biomarkers will be drawn at each time point and stored in the biobank at Ente Ospedaliero Cantonale (EOC) according to the standard procedures. These aliquotes will be used to assess FGF23 and for subsequent in-vitro evaluation of the cardiac arrhythmogenicity of patients' sera in relation to the homeostasis variation induced by HD.
- Volume assessment: total body weight will be measured at dialysis session, to calculate the net body weight increase during the long interval. Overhydration (OH) will be quantitatively assessed with a portable whole-body bioimpedance spectroscopy device (Fresenius Medical Care GmbH, Bad Homburg, Germany). The total body water (TBW), the extracellular water (ECW), the intracellular water (ICW), and the OH are calculated as previously defined
- Applanation tonometry: Central blood pressure (BP) values and aortic pressure waveforms will be obtained non-invasively directly from the common carotid artery using a validated high fidelity PulsePen tonometer (DiaTecne, San Donato Milanese, Italy). In particular, the subendocardial viability ratio (SEVR) will be calculated during the first HD session of the week according to the central BP wave form as previously reported
- Echocardiogram: If no echocardiogram exam within 12 months from study inception is available in the patient's chart, a two-dimensional echocardiographic study will be performed before the first HD session of the week utilizing a standard equipment as per standard clinical practice. Digital images will be acquired in the long axis and short axis parasternal views and the apical four and two chamber views and three-cycle clips will be stored on magnetic optical disks for future review. The presence of valvular calcification (aortic and mitral valve) as well as systolic and diastolic function assessment will be performed.
Adverse event: The occurrence of any adverse events (AE) will be recorded for the occurrence of any event from study inception until the end of the following week This exploratory study will be carried out at the Division of Nephrology, Ente Ospedaliero Cantonale (EOC), Ticino, Switzerland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects on maintenance hemodialysis | – | –The study envisages the enrolment of: * adult subjects (>18 years of age) who are able to sign an informed consent. * on maintenance HD (for at least 3 months) * without history of cardiac arrhythmias at study recruitment define as atrial fibrillation or pace-maker assisted cardiac rhythm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects on maintenance hemodialysis
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- history of cardiac arrhythmias at study recruitment define as atrial fibrillation or pace-maker assisted cardiac rhythm
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
Associations of QTc and FGF23 changes
Time frame: the primary endpoint will be assessed one hour after dialysis cessation
The primary endpoint of the study is defined as the association between QTc variations (msec) defined as a continuous variable as the difference between QTc pre-dialysis and QTc 1 hour after dialysis session completion and variations of serum levels of FGF23 defined as a continuous variable as the difference between serum levels of FGF23 at dialysis session completion and after 1-hour form dialysis session completion. We hypothesize that these time points should maximize the chance of detecting a significant association between the exposure variable (FGF23) and the outcome of interest (QTc).
2 secondary outcomes
To gauge the dynamic association between FGF23 and QTc we will also explore
Time frame: these endpoints will be assessed between dialysis session initiation and 1 hour after dialysis session cessation
To gauge the dynamic association between FGF23 and QTc we will also explore
Time frame: These endpoints will be assessed bewteen the beginning of the last dialysis of the week and the beginning of the first dialysis of the following week (72 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 29733422Arrigo M, Von Moos S, Gerritsen K, Sadoune M, Tangvoraphonkchai K, Davenport A, Mebazaa A, Segerer S, Cippa PE. Soluble CD146 and B-type natriuretic peptide dissect overhydration into functional components of prognostic relevance in haemodialysis patients. Nephrol Dial Transplant. 2018 Nov 1;33(11):2035-2042. doi: 10.1093/ndt/gfy113.
- Background: PubMed 33779046Tiong MK, Krishnasamy R, Smith ER, Hutchison CA, Ryan EG, Pascoe EM, Hawley CM, Hewitson TD, Jardine MJ, Roberts MA, Cho Y, Wong MG, Heath A, Nelson CL, Sen S, Mount PF, Vergara LA, Paul-Brent PA, Johnson DW, Toussaint ND. Effect of a medium cut-off dialyzer on protein-bound uremic toxins and mineral metabolism markers in patients on hemodialysis. Hemodial Int. 2021 Jul;25(3):322-332. doi: 10.1111/hdi.12924. Epub 2021 Mar 28.
- Background: PubMed 26558428Fu X, Cui QQ, Ning JP, Fu SS, Liao XH. High-Flux Hemodialysis Benefits Hemodialysis Patients by Reducing Serum FGF-23 Levels and Reducing Vascular Calcification. Med Sci Monit. 2015 Nov 11;21:3467-73. doi: 10.12659/msm.894894.
- Background: PubMed 37963445Sikaneta T, Ho N, Bellasi A, Mahdavi S, Taskapan H, Svendrovski A, Makanjee B, Roberts J, Wu G, Nathoo B, Tam P. QTc Interval Prolongation Is Independently Associated with FGF23 and Predicts Mortality in Predialysis Chronic Kidney Disease. Cardiorenal Med. 2024;14(1):45-57. doi: 10.1159/000535133. Epub 2024 Jan 8.
- Background: PubMed 33929896Graves JM, Vallejo JA, Hamill CS, Wang D, Ahuja R, Patel S, Faul C, Wacker MJ. Fibroblast growth factor 23 (FGF23) induces ventricular arrhythmias and prolongs QTc interval in mice in an FGF receptor 4-dependent manner. Am J Physiol Heart Circ Physiol. 2021 Jun 1;320(6):H2283-H2294. doi: 10.1152/ajpheart.00798.2020. Epub 2021 Apr 30.
- Background: PubMed 26019841Di Iorio B, Bellasi A. QT interval in CKD and haemodialysis patients. Clin Kidney J. 2013 Apr;6(2):137-43. doi: 10.1093/ckj/sfs183. Epub 2013 Jan 17.
- Background: PubMed 33767635Vazquez-Sanchez S, Poveda J, Navarro-Garcia JA, Gonzalez-Lafuente L, Rodriguez-Sanchez E, Ruilope LM, Ruiz-Hurtado G. An Overview of FGF-23 as a Novel Candidate Biomarker of Cardiovascular Risk. Front Physiol. 2021 Mar 9;12:632260. doi: 10.3389/fphys.2021.632260. eCollection 2021.
- Background: PubMed 30449517Niu J, Shah MK, Perez JJ, Airy M, Navaneethan SD, Turakhia MP, Chang TI, Winkelmayer WC. Dialysis Modality and Incident Atrial Fibrillation in Older Patients With ESRD. Am J Kidney Dis. 2019 Mar;73(3):324-331. doi: 10.1053/j.ajkd.2018.09.011. Epub 2018 Nov 16.
- Background: PubMed 31542235Rantanen JM, Riahi S, Schmidt EB, Johansen MB, Sogaard P, Christensen JH. Arrhythmias in Patients on Maintenance Dialysis: A Cross-sectional Study. Am J Kidney Dis. 2020 Feb;75(2):214-224. doi: 10.1053/j.ajkd.2019.06.012. Epub 2019 Sep 18.
- Background: PubMed 27174593Di Lullo L, Rivera R, Barbera V, Bellasi A, Cozzolino M, Russo D, De Pascalis A, Banerjee D, Floccari F, Ronco C. Sudden cardiac death and chronic kidney disease: From pathophysiology to treatment strategies. Int J Cardiol. 2016 Aug 15;217:16-27. doi: 10.1016/j.ijcard.2016.04.170. Epub 2016 May 3.
- Declaration of HelsinkiLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. IPD maybe shared upon request and in respect with the regulation on data protection
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
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.
Antonio Bellasi, MD, PhD principal investigator
Ente Ospedaliero Cantonale, Bellinzona
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 Hemodialysis, run by Antonio Bellasi at 1 site in Switzerland.
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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Bellasi, MD, PhD (+410918117119, antonio.bellasi@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations of QTc and FGF23 changes (time frame: the primary endpoint will be assessed one hour after dialysis cessation). 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 NCT06668831, which also lists 10 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 5 Aug 2025.