PSYCHE-ICD study (Psychiatric SYmptoms in Congestive Heart failure: Evaluation in ICD recipients)

Recruiting

• Conditions: heart failure; ventricular tachyarrhythmias; 10019280; 10027946

• Registration Number: NL-OMON38242
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

All patients eligible for ICD implantation.
The study is designed to evaluate patients with CHF.
Other patients eligible for ICD but without CHF will also be included to serve as an additional control group.

Exclusion Criteria

Patients unwilling to participate.
Patients in whom it is unlikely to obtain follow-up data (eg insufficient mastery of the dutch language, ICD follow up in other hospital).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters are:<br /><br><br /><br>- the occurence of ventricular tachyarrhythmias<br /><br>- parameters for depression<br /><br>- parameters for anxiety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are<br /><br>- congestive heart failure parameters<br /><br>- parameters for inflammation<br /><br>- parameters for sympathetic tone<br /><br>- occurrence of hospitalisation (due to heart failure)<br /><br>- occurrence of atrial tachyarrhythmias<br /><br>- death</p><br>