Atrial FibrillationPhase 2/3MitralPOCSNCT03682393
Post-operative Corticosteroid Treatment After Mitral Valve Surgery
A Phase 2/3 study testing Hydrocortisone in people with Atrial Fibrillation, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- open mitral valve surgery
- patients agrees to participate in the study
- adult (minimum 18 years of age)
Who cannot join
- atrial fibrillation onset before first postoperative morning
- prolonged intensive care unit stay (patient needs to stay in intensive care unit after first postoperative day)
- patient is underaged, does not want to participate or can not make the decision by himself or herself because of ie memory disability
- diabetes mellitus requiring insulin treatment and with recent hypo- or hyperglycemias which required hospital treatment
- systemic mucous infections
- known allergy or oversensitivity to hydrocortisone
Show all 15Show fewer
- Cushing syndrome
- history of psychosis
- history of ulcus or active ulcus
- chronic atrial fibrillation or atrial flutter
- corticosteroid or immunosuppressive treatment in use for any reason
- active tuberculosis infection
- severe renal impairment (serum creatinine 200 umol/l or over)
- history of deep or superficial venous trombosis
- Herpes simplex -ceratitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?
The aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study.
Read the detailed description
Voluntary adult patients, who do not have persistent atrial fibrillation before mitral valve sugery will receive either intravenous corticosteroid or placebo on three postoperative days after mitral valve surgery. End points are atrial fibrillation onset or fullfilling the three days time limit. The study is double-blinded, randomized, prospective study and the aim is to recruite 240 patients. Patients are recruited from Oulu University Hospital, Finland, Kuopio University Hospital, Finland, Helsinki University Hospital, Finland, Turku University Hospital, Finland, Tampere Univerisity Hospital, Finland, Tartu University Hospital, Estonia, Tallinn Regionaalhaigla, Estonia and Liverpool Hospital, Sydney, Australia.
- Conditions
- Atrial Fibrillation
- Being tested
- Hydrocortisone, Placebos
- Keywords
- postoperative, atrial fibrillation, post cardiac surgery, corticosteroid
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called corticosteroid
100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
PlacebosDrug
Also called placebo, saline
100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | 100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset Receives: Drug: Hydrocortisone |
| Placebos | Placebo comparator | 100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation
Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.
Measured: three days after mitral valve surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: the study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jari Halonen, MD, PhD, Principal investigator, general surgery attending, clinical teacher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682393
- Sponsor's protocol ID
- KUH5101126
- Acronym
- MitralPOCS
- Status last verified
- Mar 2022
- First submitted
- 18 Sep 2018
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are not to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?
- ClinicalTrials.gov ID
- NCT03682393
- Acronym / sponsor ID
- MitralPOCS / KUH5101126
- Conditions
- Atrial Fibrillation
- Keywords
- postoperative, atrial fibrillation, post cardiac surgery, corticosteroid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Sep 2018 (actual)
- 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 aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study.
Detailed description
Voluntary adult patients, who do not have persistent atrial fibrillation before mitral valve sugery will receive either intravenous corticosteroid or placebo on three postoperative days after mitral valve surgery. End points are atrial fibrillation onset or fullfilling the three days time limit. The study is double-blinded, randomized, prospective study and the aim is to recruite 240 patients. Patients are recruited from Oulu University Hospital, Finland, Kuopio University Hospital, Finland, Helsinki University Hospital, Finland, Turku University Hospital, Finland, Tampere Univerisity Hospital, Finland, Tartu University Hospital, Estonia, Tallinn Regionaalhaigla, Estonia and Liverpool Hospital, Sydney, Australia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Experimental | Drug: Hydrocortisone100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset |
| Placebos | Placebo comparator | Drug: Placebos100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- open mitral valve surgery
- patients agrees to participate in the study
- adult (minimum 18 years of age)
Key exclusion criteria (15 listed)
- atrial fibrillation onset before first postoperative morning
- prolonged intensive care unit stay (patient needs to stay in intensive care unit after first postoperative day)
- patient is underaged, does not want to participate or can not make the decision by himself or herself because of ie memory disability
- diabetes mellitus requiring insulin treatment and with recent hypo- or hyperglycemias which required hospital treatment
- systemic mucous infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: corticosteroid100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset | Drug | Hydrocortisone |
| PlacebosAlso: placebo, saline100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset | Drug | Placebos |
Primary outcome
atrial fibrillation
Time frame: three days after mitral valve surgery
Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No. IPD are not to be shared with other researchers.
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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.
Jari Halonen, MD, PhD principal investigator
general surgery attending, clinical teacher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydrocortisone in people with Atrial Fibrillation, run by Kuopio University Hospital at 1 site in Finland.
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 3 inclusion and 15 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: withdrawn, as of the sponsor's last update on 7 Apr 2022. 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 Finland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
atrial fibrillation (time frame: three days after mitral valve surgery). 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 7 Apr 2022.