Overview
Sponsor-declared trial summary
Heart failure
The objective is to compare the efficacy of spironolactone and eplerenone on the risk of death in patients followed in a heart failure clinic who have an indication for treatment with aldosterone antagonists due to heart failure with a reduced ejection fraction.
Key facts
- Sponsor
- Bispebjerg Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 1 Jan 2023 → ongoing
- Decision date (initial)
- 2022-12-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502239-20-00
- ClinicalTrials.gov
- NCT03984591
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The objective is to compare the efficacy of spironolactone and eplerenone on the risk of death in patients followed in a heart failure clinic who have an indication for treatment with aldosterone antagonists due to heart failure with a reduced ejection fraction.
Conditions and MedDRA coding
Heart failure
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients who are registered in the Danish Heart Failure Registry with reduced ejection fraction who have claimed at least one prescription for an aldosterone antagonist
Exclusion criteria 1
- Patients who had filled in a prescription for an aldosterone antagonist before the date of first registered visit in the Danish Heart Failure Registry and patients who have opted out of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- death
Secondary endpoints 1
- death or hospitalization for heart failure
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Spironolactone "Accord", filmovertrukne tabletter
PRD3624776 · Product
- Active substance
- Spironolactone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 126000 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA01 — SPIRONOLACTONE
- Marketing authorisation
- 56375
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Spironolactone "Accord", filmovertrukne tabletter
PRD3624777 · Product
- Active substance
- Spironolactone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 126000 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA01 — SPIRONOLACTONE
- Marketing authorisation
- 56376
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Eplerenon "Stada", filmovertrukne tabletter
PRD2905650 · Product
- Active substance
- Eplerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 1260000 mg milligram(s)
- Max treatment duration
- 84 Month(s)
- Authorisation status
- Authorised
- ATC code
- C03DA04 — -
- Marketing authorisation
- 54040
- MA holder
- STADA ARZNEIMITTEL AG
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eplerenon "Stada", filmovertrukne tabletter
PRD2984277 · Product
- Active substance
- Eplerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 126000 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA04 — -
- Marketing authorisation
- 54041
- MA holder
- STADA ARZNEIMITTEL AG
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bispebjerg Hospital
- Sponsor organisation
- Bispebjerg Hospital
- Address
- Borgmester Ib Juuls Vej 31
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Bispebjerg Hospital
- Contact name
- Jens Jakob Thune
Public contact point
- Organisation
- Bispebjerg Hospital
- Contact name
- Jens Jakob Thune
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 7,200 | 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 | 2023-01-01 | 2023-01-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-09 | Denmark | Acceptable 2022-12-16
|
2022-12-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-21 | Denmark | Acceptable 2024-04-22
|
2024-04-22 |