Cyclosporine In Takotsubo Syndrome (CIT) Trial

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to investigate the impact of repetitive acute Cyclosporine A (CsA) bolus therapy in patients suffering from TTS with an elevated risk of impaired outcome. The main question it aims to answer is whether CsA reduces myocardial injury (primary outcome). Participants will receive CsA or placebo at baseline and every 12h in the first 24h after study inclusion. Researchers will compare CsA and the placebo group to see if a) myocardial injury is reduced, and b) ejection fraction is improved compared to baseline, as well as several other secondary endpoints over a one year follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (age ≥ 18 years)

• Symptom onset \< 24h

• With a high probability of TTS:

‣ InterTAK Diagnostic Score \> 39 and

⁃ Regional wall motion abnormality (WMA) consistent with TTS; no coronary intervention (PCI), or reperfused myocardial ischemia according to MRI

• With a high probability of impaired outcome:

‣ InterTAK Prognostic Score \>15 or

⁃ GEIST Score \> 19

Locations
Other Locations
Germany
Kerckhoff Heart Center, Bad Nauheim / Gießen University
NOT_YET_RECRUITING
Bad Nauheim
Department of Cardiology, Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
RECRUITING
Berlin
Heart Centre - University Hospital Bonn
NOT_YET_RECRUITING
Bonn
Department of Cardiology, University Hospital Köln
NOT_YET_RECRUITING
Cologne
Department of Cardiology, University Hospital Dresden
NOT_YET_RECRUITING
Dresden
Cardiovascular Centre - University Hospital Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
Department of Cardiology - University Hospital Essen
NOT_YET_RECRUITING
Essen
University Medical Center Göttingen
NOT_YET_RECRUITING
Göttingen
University Medical Center Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Department of Cardiology, University Hospital Hannover
NOT_YET_RECRUITING
Hanover
Department of Cardiology, Heidelberg University Hospital
RECRUITING
Heidelberg
University Medical Center Schleswig-Holstein/Campus Kiel
NOT_YET_RECRUITING
Kiel
Leipzig Heart Center
RECRUITING
Leipzig
University Medical Center Schleswig-Holstein/Campus Lübeck
RECRUITING
Lübeck
Department of Cardiology, University Hospital Magdeburg
NOT_YET_RECRUITING
Magdeburg
Department of Cardiology, University Hospital Mainz
NOT_YET_RECRUITING
Mainz
Department of Cardiology, University Hospital Mannheim
RECRUITING
Mannheim
Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich
NOT_YET_RECRUITING
München
University Hospital rechts der Isar, Technical University of Munich
NOT_YET_RECRUITING
München
Department of Cardiology, University Hospital Ulm
NOT_YET_RECRUITING
Ulm
Contact Information
Primary
Bastian Bruns, MD
bastian.bruns@med.uni-heidelberg.de
+496221-56-36266
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-02
Participants
Target number of participants: 204
Treatments
Placebo_comparator: Placebo
A concealed 0.9% sodium chloride (NaCl) preparation will be applied intravenously at baseline, 12h, and 24h.
Experimental: CsA
Cyclosporine A will be applied intravenously at baseline, 12h, and 24h.
Related Therapeutic Areas
Sponsors
Collaborators: Coordinating Centre for Clinical Studies (KKS) Heidelberg, German Centre of Cardiovascular Research (DZHK)
Leads: University Hospital Heidelberg

This content was sourced from clinicaltrials.gov