MedTrace Logo

Cyclosporine In Takotsubo Syndrome

NCT05946772 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Takotsubo Cardiomyopathy

Interventions

DRUG

Cyclosporine A

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

DRUG

Placebo

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

Sponsors & Collaborators

  • German Centre of Cardiovascular Research (DZHK)

    collaborator UNKNOWN

  • Coordinating Centre for Clinical Studies (KKS) Heidelberg

    collaborator UNKNOWN

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Norbert Frey, MD · University Hospital Heidelberg

  • Bastian Bruns, MD · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2027-02-28
Completion
2028-02-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946772 on ClinicalTrials.gov