Cardiac Arrhythmia in Patients with End-Stage Renal Disease

NCT04841304 | Active Not Recruiting

• 1 other identifier: H-20069767
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

End Stage Renal Disease on Dialysis; Cardiac Arrhythmia; Diabetes Mellitus; Hypoglycemia

Outcome Measures

Primary Outcomes (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

  18 months

Secondary Outcomes (20)

• Atrial fibrillation

  18 months

• Supraventricular tachycardia other than atrial fibrillation

  18 months

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

  18 months

• Characterization of arrhythmias in terms of onset

  18 months

• Characterization of arrhythmias in terms of duration

  18 months

Other Outcomes (13)

• Difference in arrhythmias between patients with diabetes and patients without diabetes

  18 months

• Arrhythmias during hypoglycemia compared to euglycemia/hyperglycemia

  18 months

• The temporal distribution of arrhythmias in relation to hypoglycemic events

  18 months

Study Arms (2)

Patients receiving hemodialysis with diabetes

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

Device: Loop recorder (Reveal LINQ, Medtronic); Device: Continuous Glucose Measurement (G6, Dexcom)

Patients receiving hemodialysis without diabetes

Patients receiving chronic hemodialysis without diabetes (no known diagnosis of diabetes, and HbA1c \< 48 mmol/mol at inclusion)

Device: Loop recorder (Reveal LINQ, Medtronic); Device: Continuous Glucose Measurement (G6, Dexcom)

Interventions

Loop recorder (Reveal LINQ, Medtronic) DEVICE

Implantation of a loop-recorder

Patients receiving hemodialysis with diabetes; Patients receiving hemodialysis without diabetes

Continuous Glucose Measurement (G6, Dexcom) DEVICE

Monitoring with a continuous glucose monitor

Patients receiving hemodialysis with diabetes; Patients receiving hemodialysis without diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with diabetes:
• Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization
• 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

You may not qualify if:

• For both groups:
• Cardiac pacemaker or implantable cardioverter defibrillator (ICD)
• Known permanent (chronic) atrial fibrillation
• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev Hospital: collaborator
• Steno Diabetes Center Copenhagen: collaborator
• University of Copenhagen: collaborator
• Hillerod Hospital, Denmark: collaborator
• Holbaek Sygehus: collaborator

Study Sites (4)

Department of Nephrology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Nephrology, Herlev Hospital

Herlev, 2730, Denmark

Location

Department of Nephrology, North Zealand Hospital

Hillerød, Denmark

Location

Department of Nephrology, Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Related Publications (2)

• 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.

  PMID: 40019498 DERIVED

• 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.

  PMID: 37890966 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Arrhythmias, Cardiac; Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 12, 2021
• Study Start: June 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)