HOLT-ED: Holter-monitoring in End-stage Renal Disease

NCT ID: NCT04876963

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

268 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-09-05

Brief Summary

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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

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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

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Kidney Failure, Chronic Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Holter-monitor

7-day holtermonitoring of each patient

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Dialysis-treated end-stage renal disease
* Age ≥ 18 years
* Competence to understand the study rationale necessary for written informed consent

Exclusion Criteria

* Pre-existing pacemaker implantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Carlson

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicholas Carlson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Dept. of Nephrology, Rigshospitalet

Copenhagen, , Denmark

Site Status

Herlev Hospital

Herlev, , Denmark

Site Status

North Zealand Hospital

Hillerød, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HOLT-ED protocol 1.10

Identifier Type: -

Identifier Source: org_study_id

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