Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
62
Countries
3
Sites
10
Heart Failure
Key facts
- Sponsor
- Anacardio AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 23 Feb 2023 → 20 Oct 2025
- Decision date (initial)
- 2022-11-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500347-20-00
- WHO UTN
- U1111-1276-9209
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Heart Failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10078289 | Heart failure with reduced ejection fraction | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Anacardio AB
- Sponsor organisation
- Anacardio AB
- Address
- Nanna Svartz Vag 4
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Anacardio AB
- Contact name
- Patrik Stromberg
Public contact point
- Organisation
- Anacardio AB
- Contact name
- Goran Westerberg
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 8 | 2 |
| Netherlands | Ended | 17 | 5 |
| Sweden | Ended | 21 | 3 |
| Rest of world
United Kingdom
|
— | 16 | — |
Investigational sites
University Of Brescia
Cardiology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Sanitaria Universitaria Giuliano Isontina
Cardiology, Via Costantino Costantinides 2, 34128, Trieste
Erasmus MC
Cardiology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Utrecht
Cardiology, Heidelberglaan 100, 3584 CX, Utrecht
Amsterdam UMC
Cardiology, De Boelelaan 1117, 1081 HV, Amsterdam
Pharmaceutical Research Associates Group B.V.
Clinical Research Unit Groningen, Van Swietenlaan 6, 9728 NZ, Groningen
University Hospital Maastricht
Cardiology, P. O. Box 5800, 6202 AZ, Maastricht
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 |
|---|---|---|---|---|---|
| Italy | 2025-03-17 | 2025-09-16 | 2025-05-14 | 2025-09-10 | |
| Netherlands | 2023-08-28 | 2025-10-13 | 2023-08-28 | 2025-09-10 | |
| Sweden | 2023-02-23 | 2025-10-07 | 2023-02-23 | 2025-09-10 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-06 | Netherlands | Acceptable with conditions 2022-08-22
|
2022-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-12-09 | Acceptable with conditions | 2023-02-07 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-02-22 | Acceptable with conditions | 2023-02-22 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-03-02 | Netherlands | Acceptable with conditions | 2023-03-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-16 | Netherlands | Acceptable 2023-08-07
|
2023-08-07 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-08-07 | Netherlands | 2023-08-07 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-08-23 | Acceptable | 2023-09-27 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-01-03 | Netherlands | Acceptable | 2024-01-03 |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-01-04 | Acceptable | 2024-02-15 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-01-04 | Netherlands | Acceptable | 2024-02-16 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-03-18 | Acceptable | 2024-03-18 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-03-27 | Acceptable | ||
| 13 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-05-08 | Netherlands | Acceptable 2024-06-24
|
2024-06-24 |
| 14 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-22 | Netherlands | Acceptable 2025-02-06
|
2025-02-10 |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-14 | Acceptable | 2025-03-25 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-03-27 | Netherlands | Acceptable | 2025-03-27 |