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End Stage Renal Disease on DialysisCADDYNCT04841304

Cardiac Arrhythmia in Patients With End-Stage Renal Disease

An observational study of End Stage Renal Disease on Dialysis and Cardiac Arrhythmia, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Loop recorder (Reveal LINQ, Medtronic) and Continuous Glucose Measurement (G6, Dexcom)
Type of treatment
Medical device
How many people
70 participants
Where
4 sitesDenmark
Study dates
1 Jun 2021to 1 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 70 subjects receiving chronic hemodialysis therapy: * 35 subjects with diabetes * 35 subjects without diabetes

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • Department of Nephrology, Rigshospitalet

    Copenhagen, 2100

  • Department of Nephrology, Herlev Hospital

    Herlev, 2730

  • Department of Nephrology, North Zealand Hospital

    Hillerød

  • Department of Nephrology, Holbæk Sygehus

    Holbæk, 4300

Other trials in Denmark

About this study

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.

Read more

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.

Being tested
Loop recorder (Reveal LINQ, Medtronic), Continuous Glucose Measurement (G6, Dexcom)
Medical subject headings
Arrhythmias, Cardiac, Diabetes Mellitus, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Loop recorder (Reveal LINQ, Medtronic)Device

    Implantation of a loop-recorder

  • Continuous Glucose Measurement (G6, Dexcom)Device

    Monitoring with a continuous glucose monitor

Study groups in NCT04841304
Study groupRoleWhat they receive
Patients receiving hemodialysis with diabetesPatients 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
Receives: Device: Loop recorder (Reveal LINQ, Medtronic); Device: Continuous Glucose Measurement (G6, Dexcom)
Patients receiving hemodialysis without diabetesPatients receiving chronic hemodialysis without diabetes (no known diagnosis of diabetes, and HbA1c < 48 mmol/mol at inclusion)
Receives: Device: Loop recorder (Reveal LINQ, Medtronic); Device: Continuous Glucose Measurement (G6, Dexcom)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 18 months

Secondary outcomes (20)

  1. Atrial fibrillation

    Presence of atrial fibrillation (lasting ≥ 2 minutes)

    Measured: 18 months

  2. Supraventricular tachycardia other than atrial fibrillation

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

    Measured: 18 months

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

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

    Measured: 18 months

  4. Characterization of arrhythmias in terms of onset

    Characterization of arrhythmias in terms of onset

    Measured: 18 months

  5. Characterization of arrhythmias in terms of duration

    Characterization of arrhythmias in terms of duration

    Measured: 18 months

  6. Characterization of arrhythmias in terms of ventricular rate

    Characterization of arrhythmias in terms of ventricular rate

    Measured: 18 months

  7. Episodes of hypoglycemia

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

    Measured: 18 months

  8. Time in range

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

    Measured: 18 months

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

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

    Measured: 18 months

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

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

    Measured: 18 months

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

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

    Measured: 18 months

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

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

    Measured: 18 months

  13. Mean sensor glucose

    Mean sensor glucose derived from continuous glucose monitoring

    Measured: 18 months

  14. Glycemic variability

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

    Measured: 18 months

  15. 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

    Measured: 18 months

  16. Arrhythmia leading to a medical intervention

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

    Measured: 18 months

  17. Adverse events

    Presence of adverse events, including procedure related adverse events

    Measured: 18 months

  18. Sudden cardiac death

    Sudden cardiac death

    Measured: 18 months

  19. Cardiovascular death

    Cardiovascular death

    Measured: 18 months

  20. All-cause mortality

    All-cause mortality

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Apr 2024
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04841304
Sponsor's protocol ID
H-20069767
Acronym
CADDY
Status last verified
Aug 2026
First submitted
26 Mar 2021
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kofod DH, Diederichsen SZ, Bomholt T, Andersen MO, Andersen A, Mannheimer E, Rix M, Liem YS, Lindhard K, Hansen HP, Rydahl C, Lindhardt M, Brosen J, Schandorff K, Lange T, Norgaard K, Almdal TP, Svendsen JH, Feldt-Rasmussen B, Hornum M. Cardiac arrhythmia and hypoglycaemia among individuals with and without diabetes receiving haemodialysis (the CADDY study): a Danish multicentre cohort study. Diabetologia. 2025 Jun;68(6):1126-1139. doi: 10.1007/s00125-025-06388-5. Epub 2025 Feb 28.

    PubMed 40019498

  • Kofod DH, Diederichsen SZ, Bomholt T, Orbaek Andersen M, Rix M, Liem Y, Lindhard K, Post Hansen H, Rydahl C, Lindhardt M, Schandorff K, Lange T, Norgaard K, Almdal TP, Svendsen JH, Feldt-Rasmussen B, Hornum M. Cardiac arrhythmia and hypoglycaemia in patients receiving haemodialysis with and without diabetes (the CADDY study): protocol for a Danish multicentre cohort study. BMJ Open. 2023 Oct 27;13(10):e077063. doi: 10.1136/bmjopen-2023-077063.

    PubMed 37890966

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Disease on Dialysis and Cardiac Arrhythmia, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically significant arrhythmias (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04841304, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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