Cardiac Arrhythmia in Patients With End-Stage Renal Disease

Diabetes Mellitus Clinical Trial

— CADDY  

Official title:

Cardiac Arrhythmia in Patients With End-Stage Renal Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04841304
• Other study ID #: H-20069767
• Status: Active, not recruiting
• Start date: June 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Diabetes Mellitus
• End Stage Renal Disease on Dialysis
• Hypoglycemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Loop recorder (Reveal LINQ, Medtronic)
Implantation of a loop-recorder
• Continuous Glucose Measurement (G6, Dexcom)
Monitoring with a continuous glucose monitor

Locations

Country	Name	City	State
Denmark	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

Sponsors (6)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Herlev Hospital, Holbaek Sygehus, Nordsjaellands Hospital, Steno Diabetes Center Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in arrhythmias between patients with diabetes and patients without diabetes	Difference in arrhythmias between patients with diabetes and patients without diabetes	18 months
Other	Arrhythmias during hypoglycemia compared to euglycemia/hyperglycemia	Arrhythmias during hypoglycemia compared to euglycemia and hyperglycemia	18 months
Other	The temporal distribution of arrhythmias in relation to hypoglycemic events	Arrhythmic events one hour prior to hypoglycemia, during hypoglycemia and one hour post hypoglycemia	18 months
Other	Difference in glycemic characteristics between patients with and without diabetes	Difference in glycemic characteristics between patients with and without diabetes	18 months
Other	Correlation between pre-dialysis blood samples and arrhythmias	Correlation between pre-dialysis blood samples and arrhythmias	18 months
Other	Correlation between dialysis parameters and arrhythmias	Correlation between dialysis parameters (dialysate electrolyte concentrations and temperature) and arrhythmias	18 months
Other	Correlation between a decline in systolic blood pressure during dialysis and arrythmias	Correlation between a decline in systolic blood pressure =20 mmHg during a dialysis session and arrythmias	18 months
Other	Correlation between ultrafiltration rate and arrhythmias	Correlation between ultrafiltration rate and arrhythmias	18 months
Other	The temporal distribution of arrhythmias in relation to dialysis sessions	Arrhythmic events eight hours prior to dialysis, during dialysis, eight hours post dialysis, and in the interval between dialysis sessions	18 months
Other	Correlation between baseline clinical variables and arrhythmias	Correlation between baseline clinical variables (baseline demographic and comorbidity characteristics) and arrhythmias	18 months
Other	Correlation between baseline residual diuresis and arrhythmias	Correlation between baseline residual diuresis and arrhythmias	18 months
Other	Correlation between baseline electrocardiographic and echocardiographic markers and arrhythmias	Correlation between baseline electrocardiographic (assessed by 12-lead ECG) and echocardiographic markers (assessed by transthoracic echo) and arrhythmias	18 months
Other	Correlation between heart rate variability, daytime and nighttime heart rate, physical activity, and risk of arrhythmias	Correlation between heart rate variability, daytime and nighttime heart rate, physical activity, and risk of arrhythmias	18 months
Primary	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	18 months
Secondary	Atrial fibrillation	Presence of atrial fibrillation (lasting = 2 minutes)	18 months
Secondary	Supraventricular tachycardia other than atrial fibrillation	Presence of supraventricular tachycardia other than atrial fibrillation (lasting = 16 beats at rate = 150 beats/min)	18 months
Secondary	Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively	Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively	18 months
Secondary	Characterization of arrhythmias in terms of onset	Characterization of arrhythmias in terms of onset	18 months
Secondary	Characterization of arrhythmias in terms of duration	Characterization of arrhythmias in terms of duration	18 months
Secondary	Characterization of arrhythmias in terms of ventricular rate	Characterization of arrhythmias in terms of ventricular rate	18 months
Secondary	Episodes of hypoglycemia	Episodes of hypoglycemia <3.9 mmol/L (defined as sensor glucose below 3.9 mmol/L for = 15 min)	18 months
Secondary	Time in range	Time in range (percentage of time and amount of time with sensor glucose in range 3.9-10.0 mmol/L)	18 months
Secondary	Time below range (<3.9 mmol/L)	Time below range (percentage time and amount of time with sensor glucose <3.9 mmol/L)	18 months
Secondary	Time below range (<3.0 mmol/L)	Time below range (percentage of time and amount of time with sensor glucose <3.0 mmol/L)	18 months
Secondary	Time above range (>10.0 mmol/L)	Time above range (percentage of time and amount of time with sensor glucose >10.0 mmol/L)	18 months
Secondary	Time above range (>13.9 mmol/L)	Time above range (percentage of time and amount of time with sensor glucose >13.9 mmol/L)	18 months
Secondary	Mean sensor glucose	Mean sensor glucose derived from continuous glucose monitoring	18 months
Secondary	Glycemic variability	Glycemic variability (defined as coefficient of variation and standard deviation) derived from continuous glucose monitoring	18 months
Secondary	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	18 months
Secondary	Arrhythmia leading to a medical intervention	Presence of any arrhythmia leading to a medical intervention (defined as any change in prescribed medication)	18 months
Secondary	Adverse events	Presence of adverse events, including procedure related adverse events	18 months
Secondary	Sudden cardiac death	Sudden cardiac death	18 months
Secondary	Cardiovascular death	Cardiovascular death	18 months
Secondary	All-cause mortality	All-cause mortality	18 months