NCT02035865

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

December 2, 2013

Last Update Submit

August 2, 2021

Conditions

Psychiatric DiagnosisCognition Disorders

Keywords

Psychiatric morbidityCognitive functionHeart transplantationMortalityCardiac allograft vasculopathy

Outcome Measures

Primary Outcomes (2)

  • Psychiatric morbidity

    Psychiatric diagnoses by clinician and self-rapport

    At time of enrollment

  • Cognitive function

    Neuropsychological assessment

    At time of enrollment

Secondary Outcomes (2)

  • All cause mortality

    14 and 3 years respectively

  • Cardiac allograft vasculopathy

    14 and 3 years respectively

Other Outcomes (1)

  • Cerebral pathology

    At time of enrollment

Study Arms (2)

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surviving participants from two former studies

You may not qualify if:

  • Cognitively not capable to consent to participation and/or
  • Insufficient fluent in the Norwegian language to complete both psychiatric and neuropsychological assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Mental DisordersCognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders

Study Officials

  • Ira R. Hebold Haraldsen, MD/dr philos

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, dr.philos.

Study Record Dates

First Submitted

December 2, 2013

First Posted

January 14, 2014

Study Start

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations

NO(1)