Cardiac Arrhythmia in Patients With End-Stage Renal Disease

Rigshospitalet, Denmark70 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

End Stage Renal Disease on Dialysis Cardiac Arrhythmia Diabetes Mellitus Hypoglycemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Department of Nephrology, Rigshospitalet

Copenhagen, Denmark

Department of Nephrology, Herlev Hospital

Herlev, Denmark

Department of Nephrology, North Zealand Hospital

Hillerød, Denmark

Department of Nephrology, Holbæk Sygehus

Holbæk, Denmark

Outcomes

Primary Outcomes

Clinically significant arrhythmias

Presence of one of the items in the combined endpoint of clinically significant arrhythmias defined as: * Significant bradyarrhythmia (pause \> 3 seconds or ≥ 4 beats at rate \< 30 beats/min) * Ventricular tachycardia (lasting ≥ 16 beats at rate ≥ 150 beats/min) * Ventricular fibrillation

Time frame: 18 months

Secondary Outcomes

Atrial fibrillation

Presence of atrial fibrillation (lasting ≥ 2 minutes)

Time frame: 18 months

Supraventricular tachycardia other than atrial fibrillation

Presence of supraventricular tachycardia other than atrial fibrillation (lasting ≥ 16 beats at rate ≥ 150 beats/min)

Time frame: 18 months

Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively

Time frame: 18 months

Characterization of arrhythmias in terms of onset

Time frame: 18 months

Characterization of arrhythmias in terms of duration

Time frame: 18 months

Characterization of arrhythmias in terms of ventricular rate

Time frame: 18 months

Episodes of hypoglycemia

Episodes of hypoglycemia \<3.9 mmol/L (defined as sensor glucose below 3.9 mmol/L for ≥ 15 min)

Time frame: 18 months

Time in range

Time in range (percentage of time and amount of time with sensor glucose in range 3.9-10.0 mmol/L)

Time frame: 18 months

Time below range (<3.9 mmol/L)

Time below range (percentage time and amount of time with sensor glucose \<3.9 mmol/L)

Time frame: 18 months

Time below range (<3.0 mmol/L)

Time below range (percentage of time and amount of time with sensor glucose \<3.0 mmol/L)

Time frame: 18 months

Time above range (>10.0 mmol/L)

Time above range (percentage of time and amount of time with sensor glucose \>10.0 mmol/L)

Time frame: 18 months

Time above range (>13.9 mmol/L)

Time above range (percentage of time and amount of time with sensor glucose \>13.9 mmol/L)

Time frame: 18 months

Mean sensor glucose

Mean sensor glucose derived from continuous glucose monitoring

Time frame: 18 months

Glycemic variability

Glycemic variability (defined as coefficient of variation and standard deviation) derived from continuous glucose monitoring

Time frame: 18 months

Arrhythmia leading to the implantation of a cardiac implantable electronic device

Presence of any arrhythmia leading to the implantation of a cardiac implantable electronic device

Time frame: 18 months

Arrhythmia leading to a medical intervention

Presence of any arrhythmia leading to a medical intervention (defined as any change in prescribed medication)

Time frame: 18 months

Adverse events

Presence of adverse events, including procedure related adverse events

Time frame: 18 months

Sudden cardiac death

Time frame: 18 months

Cardiovascular death

Time frame: 18 months

All-cause mortality

Time frame: 18 months