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Takotsubo CardiomyopathyPhase 2CITNCT05946772

Cyclosporine In Takotsubo Syndrome

A Phase 2 study testing Cyclosporine A in people with Takotsubo Cardiomyopathy, run by University Hospital Heidelberg at 24 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Takotsubo Cardiomyopathy
What is being tested?
Cyclosporine A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
24 sitesGermany
Study dates
1 Feb 2025to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • History of chronic renal insufficiency (either creatinin clearance <30 ml/min/1.73m² or current medical care for severe renal insufficiency)
  • History of liver insufficiency
Show all 12Show fewer
  • Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg)
  • 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)
  • Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception
  • 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
  • Participation in other clinical trials except for non interventional trials

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bastian Bruns, MD contact

+496221-56-36266

bastian.bruns@med.uni-heidelberg.de

24 sites in 1 country

Germany24 sites, 24 recruiting

  • Kerckhoff Heart Center, Bad Nauheim / Gießen University

    Bad Nauheim

    Christian Hamm, MD

    Recruiting

  • Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin

    Ulf Landmesser, MD

    Recruiting

  • Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin

    Frank Edelmann, MD

    Henryk Dreger, MD

    Recruiting

  • Heart Centre - University Hospital Bonn

    Bonn

    Georg Nickenig, MD

    Margarita Schulz, MD

    Recruiting

  • Department of Cardiology, University Hospital Köln

    Cologne

    Roman Pfister, MD

    Recruiting

  • Department of Cardiology, University Hospital Dresden

    Dresden

    Axel Linke, MD

    Recruiting

  • Cardiovascular Centre - University Hospital Düsseldorf

    Düsseldorf

    Daniel Schreiber, MD

    Recruiting

  • Department of Cardiology - University Hospital Essen

    Essen

    Tienush Rassaf, MD

    Recruiting

  • Department of Cardiology, University Hospital Frankfurt

    Frankfurt

    David Leistner, MD

    Recruiting

  • University Medical Center Göttingen

    Göttingen

    Gerd Hasenfuß, MD

    Recruiting

  • Department of Cardiology, University Hospital Halle

    Halle

    Daniel Sedding, MD

    Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg

    Stefan Blankenberg, MD

    Recruiting

  • Department of Cardiology, Heidelberg University Hospital

    Heidelberg, 69120

    Bastian Bruns, MD

    Norbert Frey, MD

    Recruiting

  • Department of Cardiology, University Hospital Leipzig

    Leipzig

    Rolf Wachter, MD

    Recruiting

  • Leipzig Heart Center

    Leipzig

    Holger Thiele, MD

    Recruiting

  • University Medical Center Schleswig-Holstein/Campus Lübeck

    Lübeck

    Ingo Eitel, MD

    Recruiting

  • Department of Cardiology, University Hospital Magdeburg

    Magdeburg

    Rüdiger Braun-Dullaeus, MD

    Recruiting

  • Department of Cardiology, University Hospital Mainz

    Mainz

    Tommaso Gori, MD

    Maike Knorr, MD

    Recruiting

  • Department of Cardiology, University Hospital Mannheim

    Mannheim

    Ibrahim Akin, MD

    Recruiting

  • Department of Cardiology, Hospital of the Ludwig-Maximilians-University Munich

    München

    Ulrich Grabmaier, MD

    Recruiting

  • University Hospital rechts der Isar, Technical University of Munich

    München

    Karl-Ludwig Laugwitz, MD

    Isabell Bernlochner, MD

    Recruiting

  • Department of Cardiology, University Hospital Rostock

    Rostock

    Hüseyin Ince, MD

    Recruiting

  • Department of Cardiology, University Hospital Ulm

    Ulm

    Mirjam Keßler, MD

    Recruiting

  • Department of Cardiology, University Hospital Wuppertal

    Wuppertal

    Melchior Seyfarth, MD

    Recruiting

Other trials in Germany

About this study

Official title: Cyclosporine In Takotsubo Syndrome (CIT) 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.

Read the detailed description

Takotsubo syndrome (TTS) has been suggested to be caused by catecholamine excess with myocardial inflammation-enhanced cardiac injury. Substantial morbidity and mortality have repeatedly been reported, even though reduced ejection fraction frequently recovers spontaneously. So far there is no evidence-based treatment available. In a clinically relevant mouse model of catecholamine-driven TTS, cyclosporine A (CsA) bolus therapy markedly improves outcome, likely mediated via suppression of calcineurin-driven inflammation. The investigators have thus designed a pilot multicentre randomized controlled trial (RCT) to investigate the impact of repetitive CsA bolus therapy vs. placebo in acute TTS patients with an increased risk of intrahospital complications and a 32% estimated 5-year mortality. As primary outcome myocardial damage will be compared between groups via high-sensitive Troponin T plasma area under the curve (AUC). Recovery of cardiac function, the extent of myocardial oedema at 72h, length of hospital-stay, 30-day-, and 1-year composite clinical outcome as well as psychosocial and quality of life self-assessment will be secondary endpoints. The results of this trial may reveal CsA as a first pathophysiology-driven treatment option of TTS and enable a phase III follow-up trial with outcome parameters as primary endpoint.

Being tested
Cyclosporine A, Placebo
Keywords
Takotsubo syndrome, Troponin, Cyclosporine, Inflammation, Acute heart failure
Medical subject headings
Takotsubo Cardiomyopathy, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyclosporine ADrug

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

  • PlaceboDrug

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

Study groups in NCT05946772
Study groupRoleWhat they receive
PlaceboPlacebo comparatorA concealed 0.9% sodium chloride (NaCl) preparation will be applied intravenously at baseline, 12h, and 24h.
Receives: Drug: Placebo
CsAExperimentalCyclosporine A will be applied intravenously at baseline, 12h, and 24h.
Receives: Drug: Cyclosporine A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial damage

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

    Measured: baseline, hour 3, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30

Secondary outcomes (21)

  1. Change in Ejection fraction from baseline

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: baseline, hour 3, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30

  5. Fold-change in interleukin-6 plasma concentration

    The change of interleukin-6 will be compared to baseline between CsA and Placebo for multiple time points.

    Measured: baseline, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30

  6. Fold-change in procalcitonin plasma concentration

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

    Measured: baseline, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30

  7. Myocardial edema

    Cardiac MRI will be used to assess the T2 signal intensity ratio for comparison between CsA and Placebo at 72h.

    Measured: hour 72

  8. Myocardial inflammation

    Cardiac MRI will be used to assess the early gadolinium enhancement ratio for comparison between CsA and Placebo at 72h.

    Measured: hour 72

  9. Rate of cardiovascular events at day 30

    At day 30 a composite cardiovascular outcome measure includes overall mortality, stroke, myocardial infarction, heart failure hospitalization, recurrent TTS, cardiac arrest, ventricular fibrillation, ventricular tachycardia, novel atrial fibrillation, and thromboembolism. The measure is considered positive if one of the above occurs. The amount of patients with positive and negative events is then compared between the CsA and placebo arm.

    Measured: day 30

  10. Rate of cardiovascular events at 1 year

    At 1 year a composite cardiovascular outcome measure includes overall mortality, stroke, myocardial infarction, heart failure hospitalization, recurrent TTS, cardiac arrest, ventricular fibrillation, ventricular tachycardia, novel atrial fibrillation, and thromboembolism. The measure is considered positive if one of the above occurs. The amount of patients with positive and negative events is then compared between the CsA and placebo arm.

    Measured: 1 year

  11. Rate of novel disease onset

    At 30 days and 1-year novel clinical diagnoses during follow-up including cancer or neurological diseases will be assessed.

    Measured: day 30 and at 1 year

  12. Symptom burden at day 30

    Patient-reported outcome will be quantified by the Kansas City Cardiomyopathy Questionnaire after 30d and 1 year (scale 0-100 points: 0-24 points: very poor; 25-49 points: poor; 50-74 points: fair; 75-100: good).

    Measured: day 30

  13. Symptom burden at 1 year

    Patient-reported outcome will be quantified by the Kansas City Cardiomyopathy Questionnaire at 1 year (scale 0-100 points: 0-24 points: very poor; 25-49 points: poor; 50-74 points: fair; 75-100: good).

    Measured: 1 year

  14. Depression score at day 30

    Patient-reported psychosocial assessment will be quantified by the well validated German patient health questionnaire 9 (PHQ-9) scale (range 0-27 points, higher points indicate worse depressive symptoms).

    Measured: day 30

  15. Depression score at year 1

    Patient-reported psychosocial assessment will be quantified by the well validated German patient health questionnaire 9 (PHQ-9) scale (range 0-27 points, higher points indicate worse depressive symptoms).

    Measured: 1 year

  16. Anxiety score at day 30

    Patient-reported psychosocial assessment will be quantified by the well validated German generalized anxiety disorder 7 (GAD-7) questionnaire (range 0-21 points, higher points indicate worse anxiety).

    Measured: day 30

  17. Anxiety score at year 1

    Patient-reported psychosocial assessment will be quantified by the well validated German generalized anxiety disorder 7 (GAD-7) questionnaire (range 0-21 points, higher points indicate worse anxiety).

    Measured: year 1

  18. PTSD score at 30 days

    Patient-reported psychosocial assessment will be quantified by the well validated German primary care posttraumatic stress disorder questionnaire 5 (PC-PTSD-5) (0-5 points, higher points indicate more symptoms of posttraumatic stress disorder).

    Measured: day 30

  19. PTSD score at 1 year

    Patient-reported psychosocial assessment will be quantified by the well validated German primary care posttraumatic stress disorder questionnaire 5 (PC-PTSD-5) (0-5 points, higher points indicate more symptoms of posttraumatic stress disorder).

    Measured: year 1

  20. Length of intermediate care or intensive care unit stay

    Length of intermediate care or intensive care unit stay will be compared between groups

    Measured: day 30

  21. Length of hospital stay

    Length of hospital stay will be compared between groups

    Measured: day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start1 Feb 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind multicentre RCT
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05946772
Sponsor's protocol ID
DZHK29
Other IDs
DZHK29
Acronym
CIT
Status last verified
Apr 2026
First submitted
19 Jun 2023
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bruns B, Elsous N, Burghaus I, Steyrer K, Joos M, Kramer T, Scheffel M, Blankenberg S, Eitel I, Massberg S, Thiele H, Meder B, Backs J, Frey N. Rationale and design of the cyclosporine in Takotsubo syndrome (CIT) trial. Am Heart J. 2025 Nov;289:147-157. doi: 10.1016/j.ahj.2025.04.020. Epub 2025 Apr 21.

    PubMed 40268179

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclosporine A in people with Takotsubo Cardiomyopathy, run by University Hospital Heidelberg at 24 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bastian Bruns, MD (+496221-56-36266, bastian.bruns@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial damage (time frame: baseline, hour 3, hour 12, hour 24, hour 36, hour 48, hour 60, hour 72, day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05946772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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