Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT03663348

Conditions

Takotsubo Cardiomyopathy

Broken Heart Syndrome

Tako-tsubo Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Takotsubo Cardiomyopathy

Broken Heart Syndrome

Tako-tsubo Cardiomyopathy

Study ID

NCT03663348

Start date

Sep 11, 2009

Status verified date

Dec, 2025

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Physician diagnosis of takotsubo syndrome
  • Age>18 years

Exclusion Criteria:

\- Lack of capacity to provide informed consent

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Major Adverse Cardiac Events [ Time Frame: up to 10 years ]

Central Contacts and Locations

Central contacts

Harmony Reynolds, MD

brokenheartstudy@nyumc.org

Anais Hausvater, MD

brokenheartstudy@nyumc.org

Locations

NYU School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Harmony Reynolds, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-30.