Cardiac Arrhythmia in Patients with End-Stage Renal Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease on Dialysis Cardiac Arrhythmia Diabetes Mellitus Hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving hemodialysis with diabetes

Patients receiving chronic hemodialysis with a diagnose of Type 1 diabetes or Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) and receiving glucose-lowering treatment

Loop recorder (Reveal LINQ, Medtronic)

Intervention Type DEVICE

Implantation of a loop-recorder

Continuous Glucose Measurement (G6, Dexcom)

Intervention Type DEVICE

Monitoring with a continuous glucose monitor

Patients receiving hemodialysis without diabetes

Patients receiving chronic hemodialysis without diabetes (no known diagnosis of diabetes, and HbA1c \< 48 mmol/mol at inclusion)

Loop recorder (Reveal LINQ, Medtronic)

Intervention Type DEVICE

Implantation of a loop-recorder

Continuous Glucose Measurement (G6, Dexcom)

Intervention Type DEVICE

Monitoring with a continuous glucose monitor

Interventions

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Loop recorder (Reveal LINQ, Medtronic)

Implantation of a loop-recorder

Intervention Type DEVICE

Continuous Glucose Measurement (G6, Dexcom)

Monitoring with a continuous glucose monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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 Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No