Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Temporarily halted
Participants planned
111
Countries
5
Sites
19
Cardiogenic shock due to Acute Coronary Syndrome, cardiogenic shock of septic origin or cardiogenic shock due to Acute decompensated Heart Failure
Key facts
- Sponsor
- 4TEEN4 Pharmaceuticals GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 13 Jun 2025 → ongoing
- Decision date (initial)
- 2025-04-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cardiogenic shock due to Acute Coronary Syndrome, cardiogenic shock of septic origin or cardiogenic shock due to Acute decompensated Heart Failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10007625 | Cardiogenic shock | 100000004849 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
4TEEN4 Pharmaceuticals GmbH
- Sponsor organisation
- 4TEEN4 Pharmaceuticals GmbH
- Address
- Neuendorfstrasse 15a
- City
- Hennigsdorf
- Postcode
- 16761
- Country
- Germany
Scientific contact point
- Organisation
- 4TEEN4 Pharmaceuticals GmbH
- Contact name
- Mahir Karakas, Prof. Dr
Public contact point
- Organisation
- 4TEEN4 Pharmaceuticals GmbH
- Contact name
- Mahir Karakas, Prof. Dr
Locations
5 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Temporarily halted | 12 | 3 |
| Czechia | Temporarily halted | 15 | 4 |
| France | Temporarily halted | 31 | 7 |
| Netherlands | Temporarily halted | 12 | 1 |
| Poland | Temporarily halted | 31 | 4 |
| Rest of world
Armenia
|
— | 10 | — |
Investigational sites
Universitair Ziekenhuis Gent
Intensive care department, Corneel Heymanslaan 10, 9000, Gent
Azorg
Heart Center Aalst, Moorselbaan 164, 9300, Aalst
CHU Saint-Pierre
intensive care unit, 322 rue Haute, 1000, Bruxelles
Vseobecna Fakultni Nemocnice V Praze
cardiology department, U Nemocnice 499/2, Nove Mesto, Prague
Institute For Clinical And Experimental Medicine
cardiology department, Videnska 1958/9, Krc, Prague
Fakultni Nemocnice V Motole
Kardiologické kliniky, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Plzen
Kardiologická klinika, Alej Svobody 923/80, 323 00, Plzen 23
Centre Hospitalier Universitaire De Lille
cardiology intensive care unit, Boulevard Du Professeur Jules Leclercq, 59000, Lille
APHP - Hôpital Universitaire Pitié-Salpêtrière
Intensive and critical care department, 47-83 Boulevard de l'hôpital, 75013, PARIS
Centre Hospitalier Universitaire De Dijon
anesthesiology intensive care department, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Assistance Publique Hopitaux De Paris
anesthesiology and intensive care, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
CHU Dupuytren
intensive care unit, 2, avenue Martin Luther King, Limoges
Assistance Publique Hopitaux De Paris
intensive care unit, 125 Rue De Stalingrad, 93009, Bobigny Cedex
CHRU De Nancy
Intensive care, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Radboud University Medical Center
intensive care unit, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Kardiologii, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Oddział Intensywnego Nadzoru Kardiologicznego, Ul. Ziolowa 45/47, 40-635, Katowice
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Kardiologia, Ul. Borowska 213, 50-556, Wroclaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Kardiologia, Ul. Dluga 1/2, 61-848, Poznan
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 |
|---|---|---|---|---|---|
| Belgium | 2025-06-13 | 2025-08-27 | 2026-04-22 | ||
| Czechia | 2025-07-10 | 2025-12-12 | 2026-04-22 | ||
| France | 2025-06-20 | 2025-07-13 | 2026-04-22 | ||
| Netherlands | 2025-07-03 | ||||
| Poland | 2025-07-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 5 · Art. 38 CTR
Temporary halt TH-133529
- Halt date
- 2026-04-22
- Member states concerned
- Belgium
- Publication date
- 2026-05-12
- Reason
- Sponsor decision
- Explanation
- Upon Sponor's decision, the trial is temporary halted following completion of Part 1 Step 1. The benefit-risk remains positive.
- Follow-up measures
- There are no follow-up measures required, as the follow-up period (30 days) for the last participant in Part 1 Step 1 has ended.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-133536
- Halt date
- 2026-04-22
- Member states concerned
- Poland
- Publication date
- 2026-05-12
- Reason
- Sponsor decision
- Explanation
- Upon Sponor's decision, the trial is temporary halted following completion of Part 1 Step 1. The benefit-risk remains positive.
- Follow-up measures
- There are no follow-up measures required, as the follow-up period (30 days) for the last participant in Part 1 Step 1 has ended.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-133533
- Halt date
- 2026-04-22
- Member states concerned
- France
- Publication date
- 2026-05-12
- Reason
- Sponsor decision
- Explanation
- Upon Sponor's decision, the trial is temporary halted following completion of Part 1 Step 1. The benefit-risk remains positive.
- Follow-up measures
- There are no follow-up measures required, as the follow-up period (30 days) for the last participant in Part 1 Step 1 has ended.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-133535
- Halt date
- 2026-04-22
- Member states concerned
- Netherlands
- Publication date
- 2026-05-12
- Reason
- Sponsor decision
- Explanation
- Upon Sponor's decision, the trial is temporary halted following completion of Part 1 Step 1. The benefit-risk remains positive.
- Follow-up measures
- There are no follow-up measures required, as the follow-up period (30 days) for the last participant in Part 1 Step 1 has ended.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-133531
- Halt date
- 2026-04-22
- Member states concerned
- Czechia
- Publication date
- 2026-05-12
- Reason
- Sponsor decision
- Explanation
- Upon Sponor's decision, the trial is temporary halted following completion of Part 1 Step 1. The benefit-risk remains positive.
- Follow-up measures
- There are no follow-up measures required, as the follow-up period (30 days) for the last participant in Part 1 Step 1 has ended.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-05 | France | Acceptable with conditions 2025-04-07
|
2025-04-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-17 | France | Acceptable 2025-06-17
|
2025-06-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-23 | France | Acceptable 2025-12-04
|
2025-12-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-26 | France | Acceptable 2026-04-03
|
2026-04-03 |