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Cyclosporine In Takotsubo Syndrome

ConditionTakotsubo Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 -

Disqualifiers

Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI)

Infection (defined as concomitant infection with a positive blood culture at the time of study inclusion)

History of hypersensitivity to cyclosporine

History of hypersensitivity to egg, peanut or soybean proteins

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cyclosporine A

    Drug

    2.5mg/kg body weight Cyclosporine A as an intravenous bolus

  • Placebo

    Drug

    The same amount of 0.9% sodium chloride (NaCl0.9%) will be applied in an indistinguishable package as an intravenous bolus

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: CsAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Myocardial damage

High-sensitive Troponin T AUC over several time points between CsA and Placebo.

Time frame
baseline, hour 3, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30

Secondary outcomes

1

Change in Ejection fraction from baseline

Multiple timepoints will be compared to baseline between CsA and Placebo.

Time frame
baseline, hour 24, hour 48, hour 72, day 30
2

Fold-change in Troponin plasma concentration

The change of high-sensitive Troponin T will be compared to baseline between CsA and Placebo for multiple time points.

Time frame
baseline, hour 3, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30
3

Fold-change in creatine kinase plasma concentration

The change of creatine kinase will be compared to baseline between CsA and Placebo for multiple time points.

Time frame
baseline, hour 3, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30
4

Fold-change in NTproBNP plasma concentration

The change of NTproBNP will be compared to baseline between CsA and Placebo for multiple time points.

Time frame
baseline, hour 3, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30

Other outcomes

Sponsors and contacts

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University Hospital Heidelberg

Lead sponsor

German Centre of Cardiovascular Research (DZHK)

Collaborator

Coordinating Centre for Clinical Studies (KKS) Heidelberg

Collaborator

Source ClinicalTrials.gov
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