CADDY: Cardiac Arrhythmia in Patients With End-Stage Renal Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Device: Loop recorder (Reveal LINQ, Medtronic)
Implantation of a loop-recorder
Device: Continuous Glucose Measurement (G6, Dexcom)
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) |
Device: Loop recorder (Reveal LINQ, Medtronic)
Implantation of a loop-recorder
Device: Continuous Glucose Measurement (G6, Dexcom)
Monitoring with a continuous glucose monitor
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Rate of clinically significant arrhythmias [18 months]
Rate of clinically significant arrhythmias (as defined above)
- Atrial fibrillation [18 months]
Rate of atrial fibrillation (lasting more than 2 minutes)
- Supraventricular tachycardia other than atrial fibrillation [18 months]
Rate of supraventricular tachycardia other than atrial fibrillation (lasting ≥ 16 beats at rate ≥ 150 beats/min)
- Hypoglycemic events [18 months]
Rate of hypoglycemic events < 3.9 mmol/L (defined as sensor glucose below 3.9 mmol/L for ≥ 15 min)
- Time below range [18 months]
Time below range defined as percentage time with sensor glucose below 3.9 mmol/L
- Arrhythmias during hypoglycemia compared to euglycemia/hyperglycemia [18 months]
Rate of arrhythmias during hypoglycemia compared with euglycemia/hyperglycemia
- The temporal distribution of arrhythmias in relation to hypoglycemic events [18 months]
Arrhythmic events one hour prior to hypoglycemia, during hypoglycemia and one hour post hypoglycemia
- Difference in arrhythmias between patients with diabetes and patients without diabetes [18 months]
Difference in arrhythmias between patients with diabetes and patients without diabetes
- Correlation between urinary creatinine clearance and risk of arrhythmias [18 months]
Correlation between urinary creatinine clearance at baseline and risk of arrhythmias
- Correlation between macrovascular complications and risk of arrhythmias [18 months]
Correlation between macrovascular complications (myocardial infarction, stroke, peripheral vascular disease) at baseline and risk of arrhythmias
- Correlation between ultrafiltration rate and risk of arrhythmias [18 months]
Correlation between ultrafiltration rate during a dialysis session and risk of arrhythmias
- Correlation between a decline in systolic blood pressure during dialysis and risk of arrythmias [18 months]
Correlation between a decline in systolic blood pressure ≥20 mmHg during a dialysis session and risk of arrythmias
- Correlation between pre-dialysis plasma electrolyte concentrations and risk of arrhythmias [18 months]
Correlation between pre-dialysis plasma electrolyte concentrations and risk of arrhythmias
- The temporal distribution of arrhythmias in relation to dialysis sessions [18 months]
The temporal distribution of arrhythmic events in relation to dialysis sessions
- Sudden cardiac death [18 months]
Sudden cardiac death
- All-cause mortality [18 months]
All-cause mortality
Other Outcome Measures
- An arrhythmia leading to an intervention [18 months]
Presence of any arrhythmia leading to an intervention defined as implantation of a cardiac implantable electronic device or medical intervention (any change in prescribed medication)
- Presence of adverse events [18 months]
Presence of adverse events, including procedure related adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with diabetes:
-
Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization
-
Ongoing glucose-lowering treatment
-
Receiving chronic hemodialysis for more than 3 months
-
Age ≥ 18 years
Patients without diabetes:
-
HbA1c < 48 mmol/mol
-
Receiving chronic hemodialysis for more than 3 months
-
Age ≥ 18 years
Exclusion Criteria:
For both groups:
-
Already treated with pacemaker or implantable cardioverter defibrillator (ICD)
-
Permanent (chronic) atrial fibrillation
-
Previously diagnosed sustained (> 30 seconds) ventricular tachycardia (more than 200 bpm) or ventricular fibrillation (note that ventricular premature beats is not considered an exclusion), or known cardiac ion-channel diseases (such as Long QT syndrome and Brugada syndrome)
-
Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction
-
Inability to give written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- Herlev Hospital
- Holbaek Sygehus
- Steno Diabetes Center Copenhagen
- University of Copenhagen
- Nordsjaellands Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-20069767