Cardiac Arrhythmia in Patients with End-Stage Renal Disease
- Conditions
- End Stage Renal Disease on DialysisCardiac ArrhythmiaHypoglycemiaDiabetes Mellitus
- Interventions
- Device: Loop recorder (Reveal LINQ, Medtronic)Device: Continuous Glucose Measurement (G6, Dexcom)
- Registration Number
- NCT04841304
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving hemodialysis without diabetes Continuous Glucose Measurement (G6, Dexcom) Patients receiving chronic hemodialysis without diabetes (no known diagnosis of diabetes, and HbA1c \< 48 mmol/mol at inclusion) Patients receiving hemodialysis with diabetes Loop recorder (Reveal LINQ, Medtronic) 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 Patients receiving hemodialysis with diabetes Continuous Glucose Measurement (G6, Dexcom) 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 Patients receiving hemodialysis without diabetes Loop recorder (Reveal LINQ, Medtronic) Patients receiving chronic hemodialysis without diabetes (no known diagnosis of diabetes, and HbA1c \< 48 mmol/mol at inclusion)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
All-cause mortality 18 months All-cause mortality
Characterization of arrhythmias in terms of ventricular rate 18 months Characterization of arrhythmias in terms of ventricular rate
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)
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
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
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)
Characterization of arrhythmias in terms of onset 18 months Characterization of arrhythmias in terms of onset
Sudden cardiac death 18 months Sudden cardiac death
Atrial fibrillation 18 months Presence of atrial fibrillation (lasting ≥ 2 minutes)
Characterization of arrhythmias in terms of duration 18 months Characterization of arrhythmias in terms of duration
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 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)
Mean sensor glucose 18 months Mean sensor glucose derived from continuous glucose monitoring
Cardiovascular death 18 months Cardiovascular death
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)
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
Glycemic variability 18 months Glycemic variability (defined as coefficient of variation and standard deviation) derived from continuous glucose monitoring
Trial Locations
- 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