Cardiac Arrhythmia, Diabetes Mellitus, End Stage Renal Disease on Dialysis, Hypoglycemia
Conditions
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 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.
Interventions
DEVICELoop recorder (Reveal LINQ, Medtronic)
Implantation of a loop-recorder
DEVICEContinuous Glucose Measurement (G6, Dexcom)
Monitoring with a continuous glucose monitor
Sponsors
Rigshospitalet, Denmark
Herlev Hospital
Steno Diabetes Center Copenhagen
University of Copenhagen
Hillerod Hospital, Denmark
Holbaek Sygehus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant arrhythmias | 18 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation | 18 months | Presence of atrial fibrillation (lasting ≥ 2 minutes) |
| Supraventricular tachycardia other than atrial fibrillation | 18 months | Presence of supraventricular tachycardia other than atrial fibrillation (lasting ≥ 16 beats at rate ≥ 150 beats/min) |
| Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively | 18 months | Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively |
| Characterization of arrhythmias in terms of onset | 18 months | Characterization of arrhythmias in terms of onset |
| Characterization of arrhythmias in terms of duration | 18 months | Characterization of arrhythmias in terms of duration |
| Characterization of arrhythmias in terms of ventricular rate | 18 months | Characterization of arrhythmias in terms of ventricular rate |
| Episodes of hypoglycemia | 18 months | Episodes of hypoglycemia \<3.9 mmol/L (defined as sensor glucose below 3.9 mmol/L for ≥ 15 min) |
| Time in range | 18 months | Time in range (percentage of time and amount of time with sensor glucose in range 3.9-10.0 mmol/L) |
| Time below range (<3.9 mmol/L) | 18 months | Time below range (percentage time and amount of time with sensor glucose \<3.9 mmol/L) |
| Time below range (<3.0 mmol/L) | 18 months | Time below range (percentage of time and amount of time with sensor glucose \<3.0 mmol/L) |
| Time above range (>10.0 mmol/L) | 18 months | Time above range (percentage of time and amount of time with sensor glucose \>10.0 mmol/L) |
| Time above range (>13.9 mmol/L) | 18 months | Time above range (percentage of time and amount of time with sensor glucose \>13.9 mmol/L) |
| Mean sensor glucose | 18 months | Mean sensor glucose derived from continuous glucose monitoring |
| Glycemic variability | 18 months | Glycemic variability (defined as coefficient of variation and standard deviation) derived from continuous glucose monitoring |
| Arrhythmia leading to the implantation of a cardiac implantable electronic device | 18 months | Presence of any arrhythmia leading to the implantation of a cardiac implantable electronic device |
| Arrhythmia leading to a medical intervention | 18 months | Presence of any arrhythmia leading to a medical intervention (defined as any change in prescribed medication) |
| Adverse events | 18 months | Presence of adverse events, including procedure related adverse events |
| Sudden cardiac death | 18 months | Sudden cardiac death |
| Cardiovascular death | 18 months | Cardiovascular death |
| All-cause mortality | 18 months | All-cause mortality |
Countries
Denmark
Outcome results
None listed