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A phase II, multicenter, 1:1 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of bolus application of Cyclosporine A (CsA) or Placebo in patients with Takotsubo syndrome. (Cyclosporine In Takotsubo syndrome (CIT))

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511037-35-00
Acronym
CIT
Enrollment
204
Registered
2024-08-30
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cyclosporine A is a well known medication and is used to prevent rejection after solid organ transplantation and in the treatment of inflammatory disorders such as myocarditis.

Brief summary

Primary efficacy endpoint: Reduction of myocardial damage quantified by AUC of centrally measured highsensitive cardiac Troponin T (TnT) over 72 h.

Detailed description

Change in TnT/NTproBNP at T3/12/24/36/48/60/72/M1 and change in LVEF at T48/72/M1 (vs. baseline), Myocardial edema/inflammation at T48-72 (cMRI, T2 SIand EGE ratio (lake louise criteria)), Length of stay on IMC/ICU and length of hospital stay, Composite cardiovascular outcome at 30d and 1year: mortality from any cause, stroke, myocardial infarction, heart failure, hospitalization, recurrent TTS, cardiac arrest / ventricular fibrillation, ventricular tachycardia, novel atrial fibrillation, thromboembolism, LV-Thrombus, AV-Block, ventricular rupture and new onset atrial fibrillation, Psychosocial and quality of life assessments between groups at M1 vs. M12

Interventions

DRUGSandimmun® 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGSODIUM CHLORIDE

Sponsors

Universitaetsklinikum Heidelberg AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary efficacy endpoint: Reduction of myocardial damage quantified by AUC of centrally measured highsensitive cardiac Troponin T (TnT) over 72 h.

Secondary

MeasureTime frame
Change in TnT/NTproBNP at T3/12/24/36/48/60/72/M1 and change in LVEF at T48/72/M1 (vs. baseline), Myocardial edema/inflammation at T48-72 (cMRI, T2 SIand EGE ratio (lake louise criteria)), Length of stay on IMC/ICU and length of hospital stay, Composite cardiovascular outcome at 30d and 1year: mortality from any cause, stroke, myocardial infarction, heart failure, hospitalization, recurrent TTS, cardiac arrest / ventricular fibrillation, ventricular tachycardia, novel atrial fibrillation, thromboembolism, LV-Thrombus, AV-Block, ventricular rupture and new onset atrial fibrillation, Psychosocial and quality of life assessments between groups at M1 vs. M12

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026