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Can a common drug mend a broken heart? new trial aims to find out

NCT ID NCT05946772

Disease control Sponsor: University Hospital Heidelberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if the drug cyclosporine can reduce heart muscle damage in people with Takotsubo syndrome, also known as broken heart syndrome. About 204 adults at high risk for complications will receive either cyclosporine or a placebo shortly after diagnosis. Researchers will measure heart injury and function over one year to see if the drug helps the heart recover better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key inclusion criteria: * 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 Key exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

Inflammation Tako-tsubo cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Takotsubo cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cardiovascular Centre - University Hospital Düsseldorf

    RECRUITING

    Düsseldorf, Germany

  • Department of Cardiology - University Hospital Essen

    RECRUITING

    Essen, Germany

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

    RECRUITING

    Berlin, Germany

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

    RECRUITING

    Berlin, Germany

  • Department of Cardiology, Heidelberg University Hospital

    RECRUITING

    Heidelberg, 69120, Germany

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

    RECRUITING

    München, Germany

  • Department of Cardiology, University Hospital Dresden

    RECRUITING

    Dresden, Germany

  • Department of Cardiology, University Hospital Frankfurt

    RECRUITING

    Frankfurt, Germany

  • Department of Cardiology, University Hospital Halle

    RECRUITING

    Halle, Germany

  • Department of Cardiology, University Hospital Köln

    RECRUITING

    Cologne, Germany

  • Department of Cardiology, University Hospital Leipzig

    RECRUITING

    Leipzig, Germany

  • Department of Cardiology, University Hospital Magdeburg

    RECRUITING

    Magdeburg, Germany

  • Department of Cardiology, University Hospital Mainz

    RECRUITING

    Mainz, Germany

  • Department of Cardiology, University Hospital Mannheim

    RECRUITING

    Mannheim, Germany

  • Department of Cardiology, University Hospital Rostock

    RECRUITING

    Rostock, Germany

  • Department of Cardiology, University Hospital Ulm

    RECRUITING

    Ulm, Germany

  • Department of Cardiology, University Hospital Wuppertal

    RECRUITING

    Wuppertal, Germany

  • Heart Centre - University Hospital Bonn

    RECRUITING

    Bonn, Germany

  • Kerckhoff Heart Center, Bad Nauheim / Gießen University

    RECRUITING

    Bad Nauheim, Germany

  • Leipzig Heart Center

    RECRUITING

    Leipzig, Germany

  • University Hospital rechts der Isar, Technical University of Munich

    RECRUITING

    München, Germany

  • University Medical Center Göttingen

    RECRUITING

    Göttingen, Germany

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • University Medical Center Schleswig-Holstein/Campus Lübeck

    RECRUITING

    Lübeck, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.