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Active, Not Recruiting

NCT Number: NCT04841304

Cardiac Arrhythmia in Patients with End-Stage Renal Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

End Stage Renal Disease on Dialysis Arrhythmias, Cardiac Cardiac Arrhythmia Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology, Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loop recorder (Reveal LINQ, Medtronic)

Device

Implantation of a loop-recorder

Continuous Glucose Measurement (G6, Dexcom)

Device

Monitoring with a continuous glucose monitor

Primary outcomes

  1. Clinically significant arrhythmias

    Time frame: 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 outcomes

  1. Atrial fibrillation

    Time frame: 18 months

    Presence of atrial fibrillation (lasting ≥ 2 minutes)

  2. Supraventricular tachycardia other than atrial fibrillation

    Time frame: 18 months

    Presence of supraventricular tachycardia other than atrial fibrillation (lasting ≥ 16 beats at rate ≥ 150 beats/min)

  3. Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively

    Time frame: 18 months

    Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively

  4. Characterization of arrhythmias in terms of onset

    Time frame: 18 months

    Characterization of arrhythmias in terms of onset

  5. Characterization of arrhythmias in terms of duration

    Time frame: 18 months

    Characterization of arrhythmias in terms of duration

  6. Characterization of arrhythmias in terms of ventricular rate

    Time frame: 18 months

    Characterization of arrhythmias in terms of ventricular rate

  7. Episodes of hypoglycemia

    Time frame: 18 months

    Episodes of hypoglycemia <3.9 mmol/L (defined as sensor glucose below 3.9 mmol/L for ≥ 15 min)

  8. Time in range

    Time frame: 18 months

    Time in range (percentage of time and amount of time with sensor glucose in range 3.9-10.0 mmol/L)

  9. Time below range (<3.9 mmol/L)

    Time frame: 18 months

    Time below range (percentage time and amount of time with sensor glucose <3.9 mmol/L)

  10. Time below range (<3.0 mmol/L)

    Time frame: 18 months

    Time below range (percentage of time and amount of time with sensor glucose <3.0 mmol/L)

  11. Time above range (>10.0 mmol/L)

    Time frame: 18 months

    Time above range (percentage of time and amount of time with sensor glucose >10.0 mmol/L)

  12. Time above range (>13.9 mmol/L)

    Time frame: 18 months

    Time above range (percentage of time and amount of time with sensor glucose >13.9 mmol/L)

  13. Mean sensor glucose

    Time frame: 18 months

    Mean sensor glucose derived from continuous glucose monitoring

  14. Glycemic variability

    Time frame: 18 months

    Glycemic variability (defined as coefficient of variation and standard deviation) derived from continuous glucose monitoring

  15. Arrhythmia leading to the implantation of a cardiac implantable electronic device

    Time frame: 18 months

    Presence of any arrhythmia leading to the implantation of a cardiac implantable electronic device

  16. Arrhythmia leading to a medical intervention

    Time frame: 18 months

    Presence of any arrhythmia leading to a medical intervention (defined as any change in prescribed medication)

  17. Adverse events

    Time frame: 18 months

    Presence of adverse events, including procedure related adverse events

  18. Sudden cardiac death

    Time frame: 18 months

    Sudden cardiac death

  19. Cardiovascular death

    Time frame: 18 months

    Cardiovascular death

  20. All-cause mortality

    Time frame: 18 months

    All-cause mortality

Other outcomes

  1. Difference in arrhythmias between patients with diabetes and patients without diabetes

    Time frame: 18 months

    Difference in arrhythmias between patients with diabetes and patients without diabetes

  2. Arrhythmias during hypoglycemia compared to euglycemia/hyperglycemia

    Time frame: 18 months

    Arrhythmias during hypoglycemia compared to euglycemia and hyperglycemia

  3. The temporal distribution of arrhythmias in relation to hypoglycemic events

    Time frame: 18 months

    Arrhythmic events one hour prior to hypoglycemia, during hypoglycemia and one hour post hypoglycemia

  4. Difference in glycemic characteristics between patients with and without diabetes

    Time frame: 18 months

    Difference in glycemic characteristics between patients with and without diabetes

  5. Correlation between pre-dialysis blood samples and arrhythmias

    Time frame: 18 months

    Correlation between pre-dialysis blood samples and arrhythmias

  6. Correlation between dialysis parameters and arrhythmias

    Time frame: 18 months

    Correlation between dialysis parameters (dialysate electrolyte concentrations and temperature) and arrhythmias

  7. Correlation between a decline in systolic blood pressure during dialysis and arrythmias

    Time frame: 18 months

    Correlation between a decline in systolic blood pressure ≥20 mmHg during a dialysis session and arrythmias

  8. Correlation between ultrafiltration rate and arrhythmias

    Time frame: 18 months

    Correlation between ultrafiltration rate and arrhythmias

  9. The temporal distribution of arrhythmias in relation to dialysis sessions

    Time frame: 18 months

    Arrhythmic events eight hours prior to dialysis, during dialysis, eight hours post dialysis, and in the interval between dialysis sessions

  10. Correlation between baseline clinical variables and arrhythmias

    Time frame: 18 months

    Correlation between baseline clinical variables (baseline demographic and comorbidity characteristics) and arrhythmias

  11. Correlation between baseline residual diuresis and arrhythmias

    Time frame: 18 months

    Correlation between baseline residual diuresis and arrhythmias

  12. Correlation between baseline electrocardiographic and echocardiographic markers and arrhythmias

    Time frame: 18 months

    Correlation between baseline electrocardiographic (assessed by 12-lead ECG) and echocardiographic markers (assessed by transthoracic echo) and arrhythmias

  13. Correlation between heart rate variability, daytime and nighttime heart rate, physical activity, and risk of arrhythmias

    Time frame: 18 months

    Correlation between heart rate variability, daytime and nighttime heart rate, physical activity, and risk of arrhythmias

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Herlev Hospital
  • Hillerod Hospital, Denmark
  • Holbaek Sygehus
  • Steno Diabetes Center Copenhagen
  • University of Copenhagen

Registry information

Acronym: CADDY

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Apr 12, 2021
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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