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

Identification and characterisation of risk factors for sudden cardiac death in chronic kidney disease patients on regular haemodialysis using an implantable cardiac monitor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001326785

Enrollment

Registered

2013-12-02

Start date

2012-08-06

Completion date

2013-12-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this project is to study the abnormal processes in the heart that can occur in people with chronic kidney disease. These processes may lead to significant heart rhythm disturbances. In this study we will assess people with chronic kidney disease who may be at high risk of developing these disorders. By doing so we aim to identify factors in chronic kidney disease that may lead to development of life-threatening heart rhythm disorders and determine potential measures to prevent sudden death.

Interventions

The procedural component of the research will involve insertion of the implantable loop recorder under the skin in the left front chest wall region. This will take approximately 15-20 minutes and is performed under local anaesthetic. The recorder will be implanted for 2 years over which the participant will be monitored on a continuing regular basis.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

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%

Outcome results