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

August 2, 2021 updated by: Ira Hebold Haraldsen, Oslo University Hospital

Nevropsykiatri og Hjertetransplantasjon

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surviving participants from two former studies

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychiatric morbidity
Time Frame: At time of enrollment
Psychiatric diagnoses by clinician and self-rapport
At time of enrollment
Cognitive function
Time Frame: At time of enrollment
Neuropsychological assessment
At time of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
14 and 3 years respectively
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)
14 and 3 years respectively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral pathology
Time Frame: At time of enrollment
MRI of the brain
At time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Ira R. Hebold Haraldsen, MD/dr philos, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK sør-øst 2013/1260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognition Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe