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NCT Number: NCT03663348

Registry of Patients With Takotsubo Syndrome

Takotsubo syndrome is a condition which mimics acute myocardial infarction, and is diagnosed in 1.5% to 2.2% of patients referred to hospital with suspected acute coronary syndrome. It is also known as broken heart syndrome, takotsubo cardiomyopathy, stress cardiomyopathy and apical ballooning cardiomyopathy, among other names. The pathogenesis of this disorder is not well understood. Possible mechanisms include catecholamine excess, coronary artery spasm, microvascular dysfunction, among others. This is a multicenter, nation-wide, observational study of patients who were previously diagnosed with takotsubo syndrome. The investigators aim to use this registry to help plan and carry out further studies and to improve understanding of the pathophysiologic mechanisms of this syndrome. In addition participants will be followed for events, and to monitor quality of life and stress.

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Key information

Conditions

Takotsubo Cardiomyopathy Broken Heart Syndrome Cardiomyopathies Cardiovascular Diseases Heart Diseases Tako-tsubo Cardiomyopathy Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU School of Medicine

New York, 10016, United States

Location status: Recruiting

Location contact

Anais Hausvater, MD

CONTACT

[email protected]

646-501-6797

Harmony Reynolds, MD

PRINCIPAL_INVESTIGATOR

About this study

Patients are eligible to participate if they are aged 18 years or older and carry a physician confirmed diagnosis of takotsubo syndrome. Patients with a history of takotsubo syndrome will be identified via physician referral, Epic search and patient self-referral. Patients may register directly through our registry website at www.nyulmc.org/brokenheartstudy or via direct contact with the study team via e-mail or telephone. Following completion of a research authorization form and collection of medical records, study team will confirm the diagnosis of takotsubo syndrome. Data will be collected including contact information, medical history, data on the takotsubo event(s) including physician records and all relevant imaging. Participants will also be asked quality of life questionnaires and will be followed every 4 months for events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician diagnosis of takotsubo syndrome
  • Age>18 years

Exclusion criteria

  • Lack of capacity to provide informed consent

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac Events

    Time frame: up to 10 years

    Medical record review and patient report of repeat takotsubo event, MI, heart failure, unstable angina, chest pain ER visit, cardiovascular death, stroke

Secondary outcomes

  1. Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire

    Time frame: every four months up to 10 years

    Measure of quality of life

  2. Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)

    Time frame: every four months up to 10 years

    Measure of anxiety

  3. Depression assessed using the Patient Health Questionnaire (PHQ-9)

    Time frame: every four months up to 10 years

    Measure of depression

  4. Perceived stress is measured using the Perceived Stress Scale (PSS-10)

    Time frame: every four months up to 10 years

    Measure of perceived stress

Study contacts

Contact information is provided by the study sponsor or research team.

Anais Hausvater, MD

CONTACT

[email protected]

Harmony Reynolds, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

NYU Takotsubo (Broken Heart Syndrome) Registry

Important dates

Study start
2009
Primary completion
2028
Study completion
2029
First posted
Sep 10, 2018
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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