Kidney Failure, ChronicNCT04876963
HOLT-ED: Holter-monitoring in End-stage Renal Disease
An observational study of Kidney Failure, Chronic and Arrhythmias, Cardiac, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Arrhythmias, Cardiac, Heart Diseases
- What is being tested?
- Holter-monitor
- Type of treatment
- Medical device
- How many people
- 268 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Sep 2021to 31 Dec 2025
- How long will I take part?
- 1 Year
- 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
- Adult, Older adult
Study population: Patients with dialysis-treated end-stage renal disease over the age of 18 and without pacemaker implantation.
Who may be able to join
- Dialysis-treated end-stage renal disease
- Age ≥ 18 years
- Competence to understand the study rationale necessary for written informed consent
Who cannot join
- Pre-existing pacemaker implantation
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Dept. of Nephrology, Rigshospitalet
Copenhagen, Copenhagen, 2100
Herlev Hospital
Herlev
North Zealand Hospital
Hillerød
About this study
Official title: HOLT-ED: Holter-monitoring in End-stage Renal Disease - Does Burden of Arrhythmia Assessed With Systematic Holter Electrocardiogram Monitoring Affect Cardiovascular Outcomes? - A Prospective Cohort Study
The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.
Read the detailed description
Background: The risk of dying of a cardiovascular disease is 10-20 times increased in patients dependent on dialysis treatment compared to the general population. 1/3 of these deaths is caused by arrhythmia and 'sudden cardiac death'.
Purpose: Investigate the prevalence and type of arrhythmia in patients dependent on dialysis treatment, including the association with patient- and dialysis related factors and cardiovascular outcomes.
Methods: 7-days Holter-monitoring with Cortrium C3+ holter-monitor in 540 patients dependent on dialysis treatment in the Capital Region of Denmark. Continous blood glucose monitoring in a subgroup. 1-year follow-up via national registers.
Endpoints:
- Prevalence of atrial fibrillation
- Prevalence of other arrhythmia (tachycardia, bradycardia, AV-block)
- Follow-up outcomes: sudden cardiac death, cardiovascular disease and cardiovascular death
- Conditions
- Kidney Failure, Chronic, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Kidney Diseases, Renal Insufficiency, Chronic
- Being tested
- Holter-monitor
- Medical subject headings
- Kidney Failure, Chronic, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Kidney Diseases, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter-monitorDevice
7-day holtermonitoring of each patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden cardiac death / lethal arrhythmia
Risk of sudden cardiac death or lethal arrhythmia within one year
Measured: 1-year follow up
Cardiovascular death
Risk of cardiovascular death within one year
Measured: 1-year follow up
All-cause mortality
Risk of all-cause mortality within one year
Measured: 1-year follow up
Myocardial infarction or death attributable to myocardial infarction
Risk of Myocardial infarction or death attributable to myocardial infarction within one year
Measured: 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 268 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Carlson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Nicholas Carlson, MD PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876963
- Sponsor's protocol ID
- HOLT-ED protocol 1.10
- Status last verified
- May 2026
- First submitted
- 3 May 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Tabulated study data and protocols will be made available (within limitations of Danish legislation related to GDPR)
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOLT-ED: Holter-monitoring in End-stage Renal Disease - Does Burden of Arrhythmia Assessed With Systematic Holter Electrocardiogram Monitoring Affect Cardiovascular Outcomes? - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04876963
- Acronym / sponsor ID
- HOLT-ED protocol 1.10
- Conditions
- Kidney Failure, Chronic, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Kidney Diseases, Renal Insufficiency, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.
Detailed description
Background: The risk of dying of a cardiovascular disease is 10-20 times increased in patients dependent on dialysis treatment compared to the general population. 1/3 of these deaths is caused by arrhythmia and 'sudden cardiac death'.
Purpose: Investigate the prevalence and type of arrhythmia in patients dependent on dialysis treatment, including the association with patient- and dialysis related factors and cardiovascular outcomes.
Methods: 7-days Holter-monitoring with Cortrium C3+ holter-monitor in 540 patients dependent on dialysis treatment in the Capital Region of Denmark. Continous blood glucose monitoring in a subgroup. 1-year follow-up via national registers.
Endpoints:
- Prevalence of atrial fibrillation
- Prevalence of other arrhythmia (tachycardia, bradycardia, AV-block)
- Follow-up outcomes: sudden cardiac death, cardiovascular disease and cardiovascular death
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with dialysis-treated end-stage renal disease over the age of 18 and without pacemaker implantation.
Key inclusion criteria (3 listed)
- Dialysis-treated end-stage renal disease
- Age ≥ 18 years
- Competence to understand the study rationale necessary for written informed consent
Key exclusion criteria (1 listed)
- Pre-existing pacemaker implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter-monitor7-day holtermonitoring of each patient | Device | – |
Primary outcome
Sudden cardiac death / lethal arrhythmia
Time frame: 1-year follow up
Risk of sudden cardiac death or lethal arrhythmia within one year
Cardiovascular death
Time frame: 1-year follow up
Risk of cardiovascular death within one year
All-cause mortality
Time frame: 1-year follow up
Risk of all-cause mortality within one year
Myocardial infarction or death attributable to myocardial infarction
Time frame: 1-year follow up
Risk of Myocardial infarction or death attributable to myocardial infarction within one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. Tabulated study data and protocols will be made available (within limitations of Danish legislation related to GDPR)
Related trials for Kidney Failure, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Carlson, MD PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Arrhythmias, Cardiac, run by Copenhagen University Hospital, Rigshospitalet at 3 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 3 inclusion and 1 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Sudden cardiac death / lethal arrhythmia (time frame: 1-year follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.