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

Cognition Disorders Clinical Trial

Official title:

Nevropsykiatri og Hjertetransplantasjon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035865
• Other study ID #: REK sør-øst 2013/1260
• Status: Completed
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: August 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Mental Disorders
• Psychiatric Diagnosis

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral pathology	MRI of the brain	At time of enrollment
Primary	Psychiatric morbidity	Psychiatric diagnoses by clinician and self-rapport	At time of enrollment
Primary	Cognitive function	Neuropsychological assessment	At time of enrollment
Secondary	All cause mortality	Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2)	14 and 3 years respectively
Secondary	Cardiac allograft vasculopathy	Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2)	14 and 3 years respectively