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Can hidden heart rhythms explain dialysis risks?

NCT ID NCT04841304

Knowledge-focused Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study is investigating how often dangerous heart rhythm problems occur in people receiving hemodialysis for end-stage kidney disease. Researchers will implant a small device under the skin to continuously monitor heart rhythm for 18 months in 70 patients, half of whom have diabetes. They will also use continuous glucose monitors to check blood sugar levels and collect blood samples monthly. The goal is to see if diabetes, low blood sugar, or dialysis-related factors are linked to arrhythmias, which could help improve care for this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Implantable loop recorder and continuous glucose monitor
What this could lead to
If successful, this could identify which dialysis patients are at higher risk for dangerous heart rhythm problems, potentially guiding closer monitoring or preventive care.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The small size (70 patients) and specific population may limit how broadly the findings apply.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

70 people

The number who actually took part.

Started

Jun 2021

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac diabetes mellitus end stage renal failure hypoglycemia ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac arrhythmia Diabetes mellitus End stage renal disease on dialysis Hypoglycemia

Contacts and locations

Locations

  • Department of Nephrology, Herlev Hospital

    Herlev, 2730, Denmark

  • Department of Nephrology, Holbæk Sygehus

    Holbæk, 4300, Denmark

  • Department of Nephrology, North Zealand Hospital

    Hillerød, Denmark

  • Department of Nephrology, Rigshospitalet

    Copenhagen, 2100, Denmark

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