Status:
ACTIVE_NOT_RECRUITING
Cardiac Arrhythmia in Patients with End-Stage Renal Disease
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Herlev Hospital
Steno Diabetes Center Copenhagen
Conditions:
End Stage Renal Disease on Dialysis
Cardiac Arrhythmia
Eligibility:
All Genders
18+ years
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- For both groups:
- Cardiac pacemaker or implantable cardioverter defibrillator (ICD)
- Known permanent (chronic) atrial fibrillation
- 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)
- Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome)
- Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation)
- Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction
- Inability to give written informed consent
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04841304
Start Date
June 1 2021
End Date
April 1 2026
Last Update
November 18 2024
Active Locations (4)
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1
Department of Nephrology, Rigshospitalet
Copenhagen, Denmark, 2100
2
Department of Nephrology, Herlev Hospital
Herlev, Denmark, 2730
3
Department of Nephrology, North Zealand Hospital
Hillerød, Denmark
4
Department of Nephrology, Holbæk Sygehus
Holbæk, Denmark, 4300