NCT04841304Completed
Cardiac Arrhythmia in Patients With End-Stage Renal Disease
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters. After the initial 18-month follow-up, heart rhythm monitoring will continue until the ILR battery runs out for those participants who wish to continue.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 70 (actual)
- First submitted
- 26 Mar 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Chronic kidney disease
- NCT number
- NCT04841304
What you commit to
- Study type: Observational
- Participants enrolled: 70
- From 1 Jun 2021 to the primary completion date, 1 Apr 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction
Other illness
- Cardiac pacemaker or implantable cardioverter defibrillator (ICD)
- History of sustained (\> 30 seconds) ventricular tachycardia (more than 200 bpm) or ventricular fibrillation (note that ventricular premature beats is not considered an exclusion criterion)
- Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation)
Lab values
- Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome)
Other
- For both groups:
- Known permanent (chronic) atrial fibrillation
- Inability to give written informed consent
Who the study is looking for
- Patients with diabetes:
- Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization
- Treated with glucose-lowering drugs at inclusion
- Receiving in-center maintenance hemodialysis for more than 3 months
- Age ≥ 18 years
- Patients without diabetes:
- No known diagnosis of diabetes
- No previous treatment with glucose-lowering drugs
- HbA1c \< 48 mmol/mol at screening
- Receiving in-center maintenance hemodialysis for more than 3 months
- Age ≥ 18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Nephrology, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Department of Nephrology, Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Department of Nephrology, North Zealand Hospital Coordinator of this site? Confirm its status | Hillerød | Denmark | Unknown status |
| Department of Nephrology, Holbæk Sygehus Coordinator of this site? Confirm its status | Holbæk | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.