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Completed

NCT Number: NCT02035865

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

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).

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Key information

Conditions

Psychiatric Diagnosis Cognition Disorders Mental Disorders Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Psychiatric morbidity

    Time frame: At time of enrollment

    Psychiatric diagnoses by clinician and self-rapport

  2. Cognitive function

    Time frame: At time of enrollment

    Neuropsychological assessment

Secondary outcomes

  1. All cause mortality

    Time frame: 14 and 3 years respectively

    Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2)

  2. Cardiac allograft vasculopathy

    Time frame: 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 outcomes

  1. Cerebral pathology

    Time frame: At time of enrollment

    MRI of the brain

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Nevropsykiatri og Hjertetransplantasjon

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2014
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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