Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
50
Countries
1
Sites
1
New-onset atrial fibrillation
To examine pharmacokinetics of amiodarone by measuring concentrations of amiodarone and its active metabolite N-desethylamiodarone in blood, in bronchoalveolar lavage and in exhaled breath condensate during intravenous amiodarone (standard of care) versus interal amiodarone (intervention) in critically ill mechanically…
Key facts
- Sponsor
- Aalborg University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 1 Sep 2025 → ongoing
- Decision date (initial)
- 2025-06-06
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Pedersen Charity Foundation 600.000 DKK · Beckett Foundation 90.000 DKK
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Pharmacodynamic, Therapy, Efficacy
To examine pharmacokinetics of amiodarone by measuring concentrations of amiodarone and its active metabolite N-desethylamiodarone in blood, in bronchoalveolar lavage and in exhaled breath condensate during intravenous amiodarone (standard of care) versus interal amiodarone (intervention) in critically ill mechanically ventilated patients with new-onset atrial fibrillation.
Secondary objectives 3
- To examine pharmacodynamics of amiodarone with intravenous versus enteral administration focusing on conversion to sinus rhythm, oxygenation, proteomics in brochoalveolar lavage, days alive without life-support (invasive mechanical ventilation, vasopressors, dialysis), inflammatory markers (C-reactive protein and leucocytes) and liver enzymes in blood, and ICU mortality within 10 days after initiating the treatment with amiodarone.
- To examine if concentrations of amiodarone and N-desethylamiodarone in exhaled breath condensate are equal to concentrations in brochoalveolar lavage.
- To examine if proteomics analyses in exhaled breath condensate are equal to proteomics in bronchoalveolar lavage.
Conditions and MedDRA coding
New-onset atrial fibrillation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10058331 | Atrial fibrillation with rapid ventricular response | 10007541 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Pharmacokinetics and pharmacodynamics of amiodarone The purpose of the trial is to evaluate the pharmacokinetics and pharmacodynamics of intravenous amiodarone (standard of care in the intensive care unit (ICU)) versus enteral amiodarne (standard of care in non-ICU patients) and to evaluate whether it is feasible to administer the amiodarone enterally in critically ill mechanically ventilated patients to explore potentially benefits of this administration route. The pharmacokinetic will be evaluated based on measurements of amiodarone and its active metabolite N-desethylamiodarone in blood, bronchoalveolar lavage and exhaled breath condensate. The pharmacodynamic will be evaluated based on clinical parameters being part of the standard of care.
|
Randomised Controlled | None | Intravenous amiodarone for new-onset atrial fibrillation: Standard of care in critically ill mechanically ventilated patients in the intensive care unit treated with intravenous amiodarone for new-onset atrial fibrillation. Enteral amiodarone for new-onset atrial fibrillation: Standard of care in non-ICU patients treated with oral amiodarone for new-onset atrial fibrillation. |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- After publication of the last results, all de-identified individual patient data will be made available for data sharing following the Danish legislation. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. Data will be available for any research purpose to all interested parties after approval by the management committee of the trial.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521289-88-00 | Pharmacokinetics and pharmacodynamics of intravenous versus enteral amiodarone in critically ill patients with new-onset atrial fibrillation – a randomised controlled pilot trial | Aalborg University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Adults (18 years of age or older)
- Admitted to the intensive care unit
- Treated with a single dose of intravenous amiodarone 150-300 mg for new-onset atrial fibrillation
- Needing continuous treatment with amiodarone for new-onset atrial fibrillation
- Invasively mechanically ventilated
- Normal gastrointestinal function defined as uncomplicated enteral feeding with aspirate less than 300 mL per day
Exclusion criteria 5
- Persistent or paroxysmal atrial fibrillation treated with amiodarone prior to hospitalisation
- Treated with amiodarone during the current hospitalisation prior to intensive care unit admission
- Pregnancy
- Known allergy to amiodarone
- Under coercive measures
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pharmacokinetic of amiodarone
Secondary endpoints 1
- Pharmacodynamics of amiodarone
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion
PRD9861135 · Product
- Active substance
- Amiodarone Hydrochloride
- Substance synonyms
- (2-BUTYL-1-BENZOFURAN-3-YL)-[4-(2-DIETHYLAMINOETHOXY)-3,5-DIIODOPHENYL]METHANONE HYDROCHLORIDE
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01BD01 — AMIODARONE
- Marketing authorisation
- PL 01502/0122
- MA holder
- HAMELN PHARMA GMBH
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD12035940 · Product
- Active substance
- Amiodarone Hydrochloride
- Substance synonyms
- (2-BUTYL-1-BENZOFURAN-3-YL)-[4-(2-DIETHYLAMINOETHOXY)-3,5-DIIODOPHENYL]METHANONE HYDROCHLORIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ENTERAL FEEDING TUBE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01BD01 — AMIODARONE
- Marketing authorisation
- 34172
- MA holder
- SANDOZ A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aalborg University Hospital
- Sponsor organisation
- Aalborg University Hospital
- Address
- Hobrovej 18-22
- City
- Aalborg
- Postcode
- 9000
- Country
- Denmark
Scientific contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Clinical trial information desk
Public contact point
- Organisation
- Aalborg University Hospital
- Contact name
- Clinical trial information desk
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aalborg University Hospital ORG-100022335
|
Aalborg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-09-01 | 2025-12-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol_Amiopharm_version 1 | 1 |
| Protocol (for publication) | Protocol_Amiopharm_version 1_1 | 1.1 |
| Protocol (for publication) | Protocol_Amiopharm_version 1_track and changes | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Samtykke_S3_habil projekt deltager_v1_080724 | 1 |
| Subject information and informed consent form (for publication) | Samtykke_S8_stedfortrdende samtykke nrmeste parrende_v1_Amiopharm | 1 |
| Subject information and informed consent form (for publication) | Samtykke_S8_stedfortrdende samtykke_v1_080724 | 1 |
| Subject information and informed consent form (for publication) | Subject information_forsgsvrge_AMIOPHARM_track and changes_version 2 | 2 |
| Subject information and informed consent form (for publication) | Subject information_forsgsvrge_AMIOPHARM_version 2 | 2 |
| Subject information and informed consent form (for publication) | Subject information_forsgsvrge_AMIOPHARM-ICU_version 2_1 | 2.1 |
| Subject information and informed consent form (for publication) | Subject information_parrende_AMIOPHARM_track and changes_version 2 | 2 |
| Subject information and informed consent form (for publication) | Subject information_parrende_AMIOPHARM_version 2 | 2 |
| Subject information and informed consent form (for publication) | Subject information_parrende_AMIOPHARM-ICU_version 2_1 | 2.1 |
| Subject information and informed consent form (for publication) | Subject information_patient_AMIOPHARM_track and changes_version 2 | 2 |
| Subject information and informed consent form (for publication) | Subject information_patient_AMIOPHARM_version 2 | 2 |
| Subject information and informed consent form (for publication) | Subject information_patient_AMIOPHARM-ICU_version 2_1 | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amiodarone English | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Cordan English | 1 |
| Synopsis of the protocol (for publication) | Synopsis | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-06 | Denmark | Acceptable 2025-05-22
|
2025-06-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-28 | Denmark | Acceptable 2025-05-22
|
2026-05-28 |