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NCT02035865 Clinical Trial

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

Cognition Disorders Clinical Trial

Official title:
Nevropsykiatri og Hjertetransplantasjon

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02035865
Other study ID # REK sør-øst 2013/1260
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2013
Est. completion date November 2015

Study information
Verified date August 2021
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Other Cerebral pathology MRI of the brain At time of enrollment
Primary Psychiatric morbidity Psychiatric diagnoses by clinician and self-rapport At time of enrollment
Primary Cognitive function Neuropsychological assessment At time of enrollment
Secondary All cause mortality Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2) 14 and 3 years respectively
Secondary Cardiac allograft vasculopathy Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2) 14 and 3 years respectively
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