Psychiatric DiagnosisNCT02035865
Mood and Cognitive Outcome After Heart Transplantation (the MOODHEART Study)
An observational study of Psychiatric Diagnosis and Cognition Disorders, run by Oslo University Hospital at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychiatric Diagnosis, Cognition Disorders
- How many people
- 74 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surviving participants from two former studies
Who may be able to join
- Participant in one of two former studies and heart transplanted at the time of inclusion into this former study
Who cannot join
- Cognitively not capable to consent to participation and/or
- Insufficient fluent in the Norwegian language to complete both psychiatric and neuropsychological assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Psychiatric Diagnosis, Cognition Disorders
- Keywords
- Psychiatric morbidity, Cognitive function, Heart transplantation, Mortality, Cardiac allograft vasculopathy
- Medical subject headings
- Mental Disorders, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric morbidity
Psychiatric diagnoses by clinician and self-rapport
Measured: At time of enrollment
Cognitive function
Neuropsychological assessment
Measured: At time of enrollment
Secondary outcomes (2)
All cause mortality
Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2)
Measured: 14 and 3 years respectively
Cardiac allograft vasculopathy
Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2)
Measured: 14 and 3 years respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DiagnosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ira Hebold Haraldsen, Oslo University Hospital
- Investigators
- Ira R. Hebold Haraldsen, MD/dr philos, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035865
- Sponsor's protocol ID
- REK sør-øst 2013/1260
- Status last verified
- Aug 2021
- First submitted
- 2 Dec 2013
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nevropsykiatri og Hjertetransplantasjon
- ClinicalTrials.gov ID
- NCT02035865
- Acronym / sponsor ID
- REK sør-øst 2013/1260
- Conditions
- Psychiatric Diagnosis, Cognition Disorders
- Keywords
- Psychiatric morbidity, Cognitive function, Heart transplantation, Mortality, Cardiac allograft vasculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surviving participants from two former studies
Key inclusion criteria (1 listed)
- Participant in one of two former studies and heart transplanted at the time of inclusion into this former study
Key exclusion criteria (2 listed)
- Cognitively not capable to consent to participation and/or
- Insufficient fluent in the Norwegian language to complete both psychiatric and neuropsychological assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
All cause mortality
Time frame: 14 and 3 years respectively
Cardiac allograft vasculopathy
Time frame: 14 and 3 years respectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira R. Hebold Haraldsen, MD/dr philos principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Diagnosis and Cognition Disorders, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric morbidity (time frame: At time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.