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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Irah Haraldsen, Oslo University Hospital

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
Psychiatric Diagnosis Cognition Disorders

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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

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Cerebral pathology [ Time Frame: At time of enrollment ]
    MRI of the brain


Biospecimen Retention:   Samples Without DNA
Serum and plasma


Information from the National Library of Medicine

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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
Study Population
Surviving participants from two former studies
Criteria

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

Information from the National Library of Medicine

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


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Ira R. Hebold Haraldsen, MD/dr philos Oslo University Hospital
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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
Keywords provided by Irah Haraldsen, Oslo University Hospital:
Psychiatric morbidity
Cognitive function
Heart transplantation
Mortality
Cardiac allograft vasculopathy
Additional relevant MeSH terms:
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Cognition Disorders
Mental Disorders
Neurocognitive Disorders