Cardiac Arrhythmia in Patients with End-Stage Renal Disease (CADDY)

Rigshospitalet

Status: Active, not recruiting

Conditions: Hypoglycemia; Diabetes Mellitus; End Stage Renal Disease on Dialysis; Cardiac Arrhythmia

Treatments: Device: Loop recorder (Reveal LINQ, Medtronic); Device: Continuous Glucose Measurement (G6, Dexcom)

Study type: Observational

Funder types: Other

Identifiers

NCT04841304

H-20069767

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

Patients receiving hemodialysis with diabetes

Description:

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

Treatment:

Device: Continuous Glucose Measurement (G6, Dexcom)

Device: Loop recorder (Reveal LINQ, Medtronic)

Patients receiving hemodialysis without diabetes

Description:

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

Treatment:

Device: Continuous Glucose Measurement (G6, Dexcom)

Device: Loop recorder (Reveal LINQ, Medtronic)