Fact CheckerSign in

NCT05946772RecruitingPhase 2

Cyclosporine In Takotsubo Syndrome

Cyclosporine In Takotsubo Syndrome (CIT) Trial

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
204 (estimated)
First submitted
19 Jun 2023
Start date
1 Feb 2025
Primary completion date
Feb 2027
Lead sponsor
University Hospital Heidelberg
NCT number
NCT05946772

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 204
  • From 1 Feb 2025 to the primary completion date, Feb 2027
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Infection (defined as concomitant infection with a positive blood culture at the time of study inclusion)
  • Current medication with any compound containing Hypericum perforatum (St. John's worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine (Rosuvastatine \>5mg within 24h intake\<48h before IMP administration)
  • Any disorder associated with immunological dysfunction ≤6 months prior to presentation (autoimmune disease, known positive serology for HIV or hepatitis)
  • Immunosuppressive, chemotherapeutical, or antibody treatment

Other illness

  • Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI)
  • History of hypersensitivity to cyclosporine
  • History of hypersensitivity to egg, peanut or soybean proteins
  • History of liver insufficiency
  • Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure \>180mmHg and/or diastolic blood pressure \>110mmHg)

Lab values

  • History of chronic renal insufficiency (either creatinin clearance \<30 ml/min/1.73m² or current medical care for severe renal insufficiency)

Age

  • Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception

Other

  • Participation in other clinical trials except for non interventional trials

Who the study is looking for

  • Patients aged over 18
  • Enrollment and first IMP administration within 24 hours after cardiac catheterization
  • Regional Wall Motion Abnormality (WMA) consistent with TTS in angiography or echocardiography
  • InterTAK prognostic score- or a GEIST Score ≥ 9 -
  • Written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kerckhoff Heart Center, Bad Nauheim / Gießen University
Coordinator of this site? Confirm its status
Bad NauheimGermanyRecruiting
Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Heart Centre - University Hospital Bonn
Coordinator of this site? Confirm its status
BonnGermanyRecruiting
Department of Cardiology, University Hospital Köln
Coordinator of this site? Confirm its status
CologneGermanyRecruiting
Department of Cardiology, University Hospital Dresden
Coordinator of this site? Confirm its status
DresdenGermanyRecruiting
Cardiovascular Centre - University Hospital Düsseldorf
Coordinator of this site? Confirm its status
DüsseldorfGermanyRecruiting
Department of Cardiology - University Hospital Essen
Coordinator of this site? Confirm its status
EssenGermanyRecruiting
Department of Cardiology, University Hospital Frankfurt
Coordinator of this site? Confirm its status
FrankfurtGermanyRecruiting
University Medical Center Göttingen
Coordinator of this site? Confirm its status
GöttingenGermanyRecruiting
Department of Cardiology, University Hospital Halle
Coordinator of this site? Confirm its status
HalleGermanyRecruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyRecruiting
Department of Cardiology, Heidelberg University Hospital
Coordinator of this site? Confirm its status
HeidelbergGermanyRecruiting
Leipzig Heart Center
Coordinator of this site? Confirm its status
LeipzigGermanyRecruiting
Department of Cardiology, University Hospital Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyRecruiting
University Medical Center Schleswig-Holstein/Campus Lübeck
Coordinator of this site? Confirm its status
LübeckGermanyRecruiting
Department of Cardiology, University Hospital Magdeburg
Coordinator of this site? Confirm its status
MagdeburgGermanyRecruiting
Department of Cardiology, University Hospital Mainz
Coordinator of this site? Confirm its status
MainzGermanyRecruiting
Department of Cardiology, University Hospital Mannheim
Coordinator of this site? Confirm its status
MannheimGermanyRecruiting
Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich
Coordinator of this site? Confirm its status
MünchenGermanyRecruiting
University Hospital rechts der Isar, Technical University of Munich
Coordinator of this site? Confirm its status
MünchenGermanyRecruiting
Department of Cardiology, University Hospital Rostock
Coordinator of this site? Confirm its status
RostockGermanyRecruiting
Department of Cardiology, University Hospital Ulm
Coordinator of this site? Confirm its status
UlmGermanyRecruiting
Department of Cardiology, University Hospital Wuppertal
Coordinator of this site? Confirm its status
WuppertalGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.