Mood and Cognitive Outcome After Heart Transplantation (the MOODHEART Study)
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ClinicalTrials.gov Identifier: NCT02035865 |
Recruitment Status : Unknown
Verified April 2015 by Irah Haraldsen, Oslo University Hospital.
Recruitment status was: Enrolling by invitation
First Posted : January 14, 2014
Last Update Posted : April 21, 2015
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Condition or disease |
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Psychiatric Diagnosis Cognition Disorders |
Study Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Nevropsykiatri og Hjertetransplantasjon |
Study Start Date : | December 2013 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2016 |

Group/Cohort |
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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'
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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)
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- Psychiatric morbidity [ Time Frame: At time of enrollment ]Psychiatric diagnoses by clinician and self-rapport
- Cognitive function [ Time Frame: At time of enrollment ]Neuropsychological assessment
- 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)
- 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)
- Cerebral pathology [ Time Frame: At time of enrollment ]MRI of the brain
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035865
Norway | |
Oslo University Hospital | |
Oslo, Norway, 0424 |
Principal Investigator: | Ira R. Hebold Haraldsen, MD/dr philos | Oslo University Hospital |
Responsible Party: | Irah Haraldsen, MD, dr.philos., Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT02035865 |
Other Study ID Numbers: |
REK sør-øst 2013/1260 |
First Posted: | January 14, 2014 Key Record Dates |
Last Update Posted: | April 21, 2015 |
Last Verified: | April 2015 |
Psychiatric morbidity Cognitive function Heart transplantation Mortality Cardiac allograft vasculopathy |
Cognition Disorders Mental Disorders Neurocognitive Disorders |