Registry of Patients With Takotsubo Syndrome

NYU Takotsubo (Broken Heart Syndrome) Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Tako-tsubo Cardiomyopathy; Takotsubo Cardiomyopathy; Broken Heart Syndrome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Harmony Reynolds, MD; Email: brokenheartstudy@nyumc.org
• Study Contact Backup: Name: Anais Hausvater, MD; Email: brokenheartstudy@nyumc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU School of Medicine
      • Contact: Anais Hausvater, MD; Phone Number: 646-501-6797; Email: brokenheartstudy@nyumc.org
      • Principal Investigator: Harmony Reynolds, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 106 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with history of takotsubo syndrome

Description

Inclusion Criteria:

• Physician diagnosis of takotsubo syndrome
• Age>18 years

Exclusion Criteria:

- Lack of capacity to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events	Medical record review and patient report of repeat takotsubo event, MI, heart failure, unstable angina, chest pain ER visit, cardiovascular death, stroke	up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire	Measure of quality of life	every four months up to 10 years
Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)	Measure of anxiety	every four months up to 10 years
Depression assessed using the Patient Health Questionnaire (PHQ-9)	Measure of depression	every four months up to 10 years
Perceived stress is measured using the Perceived Stress Scale (PSS-10)	Measure of perceived stress	every four months up to 10 years

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2009
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Estimated): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Ventricular Dysfunction; Ventricular Dysfunction, Left; Takotsubo Cardiomyopathy
• Other Study ID Numbers: 09-0746

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No