Identification and characterisation of risk factors for atrial and ventricular arrhythmias in chronic kidney disease (CKD) patients using implantable cardiac monitoring

Not Applicable

Active, not recruiting

• Conditions: Dialysis; Sudden Cardiac Death; Chronic Kidney Disease; Cardiovascular - Other cardiovascular diseases; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12613001326785
• Lead Sponsor: St Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Any CKD patient on haemodialysis
2. Stable medical therapy for at least one month.
3. All patients must have no prior history of clinical ventricular tachyarrhythmias (including ventricular fibrillation or cardiac arrest) or syncope.

Exclusion Criteria

1. Pacemaker or Automatic Implantable Cardioverter-Defibrillator in-situ
2. Unstable angina pectoris
3. Uncontrolled hypertension.
4. Known coagulopathy, thrombophilia or contraindications to full systemic anticoagulation
with heparin or warfarin (e.g. haemorrhagic stroke, active bleeding, heparin induced
thrombocytopenic thrombotic syndrome etc.)
5. Inability to provide informed consent
6. Women who are pregnant
7. Children and/or young people (ie. <18 years)
8. Patients experiencing NYHA class IV symptoms and/or LVEF < 35%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sudden cardiac death will be determined by a consensus adjudication committee after assessment of electrocardiogram records of the implantable loop recorder, autopsy reports, holter recordings or telemetry tracings and hospital discharge documentation/medical records.[Assessed at 12 and 24 months from insertion of implantable loop recorder.]

Secondary Outcome Measures

Name	Time	Method
Significant Arrhythmias will be determined by a consensus adjudication committee after assessment of electrocardiogram records of the implantable loop recorder, holter recordings or telemetry tracings and hospital discharge documentation/medical records.[Assessed at 12 and 24 months from insertion of implantable loop recorder.]