Investigating the link between FGF23 and heart rhythm issues in dialysis patients
Fibroblast Growth Factor 23 and Risk of Cardiac Arrhythmias in Hemodialysis Patients: a Proof-of-concept Study (FibCa-HD)
This study is trying to see if levels of a protein called FGF23 are linked to heart rhythm problems in patients who are on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT06668831 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between fibroblast growth factor 23 (FGF23) levels and cardiac arrhythmias in patients undergoing maintenance hemodialysis. By monitoring changes in FGF23 during dialysis and their association with electrocardiographic abnormalities, particularly QTc prolongation, the study seeks to enhance understanding of the mechanisms that may lead to heart rhythm disturbances in chronic kidney disease patients. The research will be conducted at a single center, focusing on a well-characterized group of hemodialysis patients over a defined period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been on maintenance hemodialysis for at least three months.
Not a fit: Patients with a history of cardiac arrhythmias or those requiring a pacemaker will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing cardiac risks in hemodialysis patients.
How similar studies have performed: While the specific approach of linking FGF23 to cardiac arrhythmias in hemodialysis patients is exploratory, previous studies have indicated potential associations between FGF23 and cardiovascular risks.
Eligibility criteria
Show full inclusion / exclusion criteria
The study envisages the enrolment of: * Adult subjects (\>18 years of age) who can sign an informed consent. * on maintenance HD (for at least 3 months) Exclusion Criteria: * history of cardiac arrhythmias at study recruitment define as atrial fibrillation or pace-maker assisted cardiac rhythm
Where this trial is running
Lugano
- Servizio di Nefrologia, Ospedale Regionale di Lugano, Civico — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Antonio Bellasi, MD, PhD — Ente Ospedaliero Cantonale, Bellinzona
- Study coordinator: Antonio Bellasi, MD, PhD
- Email: antonio.bellasi@eoc.ch
- Phone: +410918117119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.