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

NCT ID: NCT02035865

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Psychiatric Diagnosis Cognition Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants from former study 1

Surviving participants from a former study called 'Psykosomale faktorer hos pasienter med hjertesvikt og hos hjertetransplanterte'

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ira Hebold Haraldsen

MD, dr.philos.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ira R. Hebold Haraldsen, MD/dr philos

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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REK sør-øst 2013/1260

Identifier Type: -

Identifier Source: org_study_id

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