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

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02035865

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Diagnosis Cognition Disorders

Study Design

Study Type:

Observational

Actual Enrollment :

74 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Nevropsykiatri og Hjertetransplantasjon

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Participants from former study 1 Surviving participants from a former study called 'Psykosomale faktorer hos pasienter med hjertesvikt og hos hjertetransplanterte'
Participants from former study 2 Surviving participants, included at the Norwegian centre, from a study called 'Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance (SCHEDULE)' (NCT01266148)

Outcome Measures

Primary Outcome Measures

Psychiatric morbidity [At time of enrollment]
Psychiatric diagnoses by clinician and self-rapport
Cognitive function [At time of enrollment]
Neuropsychological assessment

Secondary Outcome Measures

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)
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)

Other Outcome Measures

Cerebral pathology [At time of enrollment]
MRI of the brain

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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