Takotsubo CardiomyopathyNCT03663348
Registry of Patients With Takotsubo Syndrome
An observational study of Takotsubo Cardiomyopathy and Broken Heart Syndrome, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Takotsubo Cardiomyopathy, Broken Heart Syndrome, Tako-tsubo Cardiomyopathy
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2009to 1 Aug 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with history of takotsubo syndrome
Who may be able to join
- Physician diagnosis of takotsubo syndrome
- Age>18 years
Who cannot join
- Lack of capacity to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Harmony Reynolds, MD contact
Anais Hausvater, MD contact
United States1 site, 1 recruiting
- Recruiting
NYU School of Medicine
New York, New York, 10016
Anais Hausvater, MD, 646-501-6797, brokenheartstudy@nyumc.org
Harmony Reynolds, MD
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Takotsubo Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 10 years
Secondary outcomes (4)
Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire
Measure of quality of life
Measured: every four months up to 10 years
Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)
Measure of anxiety
Measured: every four months up to 10 years
Depression assessed using the Patient Health Questionnaire (PHQ-9)
Measure of depression
Measured: every four months up to 10 years
Perceived stress is measured using the Perceived Stress Scale (PSS-10)
Measure of perceived stress
Measured: every four months up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start11 Sep 2009
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663348
- Sponsor's protocol ID
- 09-0746
- Status last verified
- Dec 2025
- First submitted
- 16 May 2018
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYU Takotsubo (Broken Heart Syndrome) Registry
- ClinicalTrials.gov ID
- NCT03663348
- Acronym / sponsor ID
- 09-0746
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Sep 2009 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with history of takotsubo syndrome
Key inclusion criteria (2 listed)
- Physician diagnosis of takotsubo syndrome
- Age>18 years
Key exclusion criteria (1 listed)
- Lack of capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire
Time frame: every four months up to 10 years
Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)
Time frame: every four months up to 10 years
Depression assessed using the Patient Health Questionnaire (PHQ-9)
Time frame: every four months up to 10 years
Perceived stress is measured using the Perceived Stress Scale (PSS-10)
Time frame: every four months up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harmony Reynolds, MD contact
Anais Hausvater, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takotsubo Cardiomyopathy and Broken Heart Syndrome, run by NYU Langone Health at 1 site in United States.
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 2 inclusion and 1 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Harmony Reynolds, MD (brokenheartstudy@nyumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.