Clinical trial NCT04841304: Cardiac Arrhythmia in Patients with End-Stage Renal Disease
Official title: Cardiac Arrhythmia in Patients with End-Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: End Stage Renal Disease on Dialysis
Cardiac Arrhythmia
Diabetes Mellitus
Hypoglycemia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Steno Diabetes Center Copenhagen
name: University of Copenhagen
name: Hillerod Hospital, Denmark
name: Holbaek Sygehus
First posted: 2021-04-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 subjects receiving chronic hemodialysis therapy:

* 35 subjects with diabetes
* 35 subjects without diabetes

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinically significant arrhythmias
timeFrame: 18 months
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: 18 months
measure: Supraventricular tachycardia other than atrial fibrillation
timeFrame: 18 months
measure: Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively
timeFrame: 18 months
measure: Characterization of arrhythmias in terms of onset
timeFrame: 18 months
measure: Characterization of arrhythmias in terms of duration
timeFrame: 18 months
measure: Characterization of arrhythmias in terms of ventricular rate
timeFrame: 18 months
measure: Episodes of hypoglycemia
timeFrame: 18 months
measure: Time in range
timeFrame: 18 months
measure: Time below range (<3.9 mmol/L)
timeFrame: 18 months
measure: Time below range (<3.0 mmol/L)
timeFrame: 18 months
measure: Time above range (>10.0 mmol/L)
timeFrame: 18 months
measure: Time above range (>13.9 mmol/L)
timeFrame: 18 months
measure: Mean sensor glucose
timeFrame: 18 months
measure: Glycemic variability
timeFrame: 18 months
measure: Arrhythmia leading to the implantation of a cardiac implantable electronic device
timeFrame: 18 months
measure: Arrhythmia leading to a medical intervention
timeFrame: 18 months
measure: Adverse events
timeFrame: 18 months
measure: Sudden cardiac death
timeFrame: 18 months
measure: Cardiovascular death
timeFrame: 18 months
measure: All-cause mortality
timeFrame: 18 months
Other outcomes:
measure: Difference in arrhythmias between patients with diabetes and patients without diabetes
timeFrame: 18 months
measure: Arrhythmias during hypoglycemia compared to euglycemia/hyperglycemia
timeFrame: 18 months
measure: The temporal distribution of arrhythmias in relation to hypoglycemic events
timeFrame: 18 months
measure: Difference in glycemic characteristics between patients with and without diabetes
timeFrame: 18 months
measure: Correlation between pre-dialysis blood samples and arrhythmias
timeFrame: 18 months
measure: Correlation between dialysis parameters and arrhythmias
timeFrame: 18 months
measure: Correlation between a decline in systolic blood pressure during dialysis and arrythmias
timeFrame: 18 months
measure: Correlation between ultrafiltration rate and arrhythmias
timeFrame: 18 months
measure: The temporal distribution of arrhythmias in relation to dialysis sessions
timeFrame: 18 months
measure: Correlation between baseline clinical variables and arrhythmias
timeFrame: 18 months
measure: Correlation between baseline residual diuresis and arrhythmias
timeFrame: 18 months
measure: Correlation between baseline electrocardiographic and echocardiographic markers and arrhythmias
timeFrame: 18 months
measure: Correlation between heart rate variability, daytime and nighttime heart rate, physical activity, and risk of arrhythmias
timeFrame: 18 months
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nephrology, Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Nephrology, Herlev Hospital
city: Hillerød
country: Denmark
facility: Department of Nephrology, North Zealand Hospital
city: Holbæk
country: Denmark
facility: Department of Nephrology, Holbæk Sygehus
Study officials:
References: