Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
218
Countries
1
Sites
2
Unexplained cardiac arrest patients after thorough investigations (Idiopathic ventricular fibrillation, IVF)
To investigate the effect on beta-blocker treatment in IVF patients by ICD data (appropriate ATP and shock)
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 22 Feb 2019 → ongoing
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- The Novo Nordisk Foundation · Per Henriksen Foundation · The Danish Heart Foundation · RH research funds
External identifiers
- EU CT number
- 2024-518057-41-00
- EudraCT number
- 2018-001683-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Prophylaxis
To investigate the effect on beta-blocker treatment in IVF patients by ICD data (appropriate ATP and shock)
Secondary objectives 1
- To assess quality of life in cardiac arrest survivors
Conditions and MedDRA coding
Unexplained cardiac arrest patients after thorough investigations (Idiopathic ventricular fibrillation, IVF)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Unexplained cardiac arrest survivors aged 18 or older
- All patients surviving a cardiac arrest will receive a minimum diagnostic work-up consisting of an ECG, a Holter monitor during admission, an echocardiography, consecutive blood samples during the first 24 hours, and a coronary angiography or a cardiac CT-scan. Further evaluation with SAECG, stress-ECG, Cardiac MRI, and Sodium-channel blocker testing will be performed subsequently
- All patients will have an ICD implanted
Exclusion criteria 2
- Age under 18 years
- Explained cardiac arrest
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Endpoint will be one of the following 1) first appropriate therapy by ICD, 2) aborted shock or non-sustained VF, where the treating physician opts XML File Identifier: kg77bYwzweR7n2lb9bLtT2kXLeo= Page 25/34 for a change in medication, or 3) 3 years after randomizationdischarge, whichever comes first.
Secondary endpoints 1
- Quality of life after 1 year
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
—
SCP192030 · ATC
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AA12 — NADOLOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB14568MIG · Substance
- Active substance
- Metoprolol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1160479 · ATC
- Active substance
- Atenolol
- Substance synonyms
- 2-[4-[2-HYDROXY-3-(PROPAN-2-YLAMINO)PROPOXY]PHENYL]ACETAMIDE
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AB03 — ATENOLOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129860 · ATC
- Active substance
- Propranolol Hydrochloride
- Substance synonyms
- PROPRANOLOLI HYDROCHLORIDUM, PROPRANOLOL HYDROCHLORIIDE, 1-NAPHTHALEN-1-YLOXY-3-(PROPAN-2-YLAMINO)PROPAN-2-OL HYDROCHLORIDE
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AA05 — PROPRANOLOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP109534428 · ATC
- Active substance
- Bisoprolol Fumarate
- Substance synonyms
- BUT-2-ENEDIOIC ACID: 1-(PROPAN-2-YLAMINO)-3-[4-(2-PROPAN-2-YLOXYETHOXYMETHYL)PHENOXY]PROPAN-2-OL
- Route of administration
- ORAL USE
- Max daily dose
- 2.50 mg milligram(s)
- Max total dose
- 2.50 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- C07AB07 — BISOPROLOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Bo Gregers Winkel
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Bo Gregers Winkel
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 218 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Odense University Hospital
Cardiology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Cardiology, Blegdamsvej 9, 2100, Copenhagen Oe
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 | 2019-02-22 | 2019-02-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518057-41-00 | 7 |
| Protocol (for publication) | D4_ Patient facing documents_SF-36 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF medical study | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF risk factor study competent | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF risk factor study incompetent | 1.4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Atenolol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Bisoprolol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Metoprolol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Nadolol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Propranolol | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Denmark | Acceptable 2024-10-16
|
2024-10-23 |