Mood and Cognitive Outcome After Heart Transplantation (the MOODHEART Study)

Completed

• Conditions: Psychiatric Diagnosis; Cognition Disorders

• Registration Number: NCT02035865
• Lead Sponsor: Oslo University Hospital

Brief Summary

The investigators aim at characterizing neuropsychiatric consequences of heart transplantation (HTX) and at assessing the impact of depressive symptoms after HTX on mortality and cardiac allograft vasculopathy (CAV).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Participant in one of two former studies and heart transplanted at the time of inclusion into this former study

Exclusion Criteria

• Cognitively not capable to consent to participation and/or
• Insufficient fluent in the Norwegian language to complete both psychiatric and neuropsychological assessment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychiatric morbidity	At time of enrollment	Psychiatric diagnoses by clinician and self-rapport
Cognitive function	At time of enrollment	Neuropsychological assessment

Secondary Outcome Measures

Name	Time	Method
Cardiac allograft vasculopathy	14 and 3 years respectively	Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2)
All cause mortality	14 and 3 years respectively	Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2)

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway