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

NCT04876963 | Active Not Recruiting

• 1 other identifier: HOLT-ED protocol 1.10
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 3

Brief 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 and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Sudden cardiac death / lethal arrhythmia

  Risk of sudden cardiac death or lethal arrhythmia within one year

  1-year follow up

• Cardiovascular death

  Risk of cardiovascular death within one year

  1-year follow up

• All-cause mortality

  Risk of all-cause mortality within one year

  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

  1-year follow up

Other Outcomes (2)

• Clinical hypoglycemia

  Baseline

• De novo cardiac arrhythmia (atrial fibrillation or flutter, advanced second-degree or third degree

  Baseline

Interventions

Holter-monitor DEVICE

7-day holtermonitoring of each patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dialysis-treated end-stage renal disease over the age of 18 and without pacemaker implantation.

You may qualify if:

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

You may not qualify if:

• Pre-existing pacemaker implantation

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (3)

Dept. of Nephrology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

North Zealand Hospital

Hillerød, Denmark

Location

MeSH Terms

Conditions

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

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Nicholas Carlson, MD PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: September 1, 2021
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: within 1 year of study completion
• Access Criteria: Data access will be available upon approval via Statistics Denmark

Locations

DK (3)