The Broken Heart Study II (BHS-II) (BHS)

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    The Miriam Hospital
Updated on 7 April 2023


The goals of this study are as follows:

  1. To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS).
  2. To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event.


Newly admitted patients with a validated diagnosis of Takotsubo Syndrome (TS; n=106) will be enrolled from 3 large medical centers in the Providence, Rhode Island area. Between 2 and 4 weeks after discharge, clinically stable patients will undergo an in-person comprehensive interview to identify the events proximal to the onset of TS symptoms, complete a battery of psychosocial questionnaires and undergo a validated laboratory stress protocol. Baseline and reactive changes in measures of autonomic nervous system activity (epinephrine and norepinephrine - primary outcome), and in the secondary outcomes of cardiac vagal control and left ventricular function (ejection fraction; regional and global longitudinal strain assessed with speckle tracking echocardiography) will be assessed. Echocardiographic evaluations will be repeated 12 months thereafter together with information on major adverse cerebrovascular events.

Condition Takotsubo Cardiomyopathy
Treatment Stress reactivity test
Clinical Study IdentifierNCT04325321
SponsorThe Miriam Hospital
Last Modified on7 April 2023


Yes No Not Sure

Inclusion Criteria

Age >=18
A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
Ability to understand and speak English

Exclusion Criteria

Inability or unwillingness to give informed consent
Severe cognitive impairment
Uncontrolled hypertension
Acute psychosis
High suicidal risk
If the participant is clinically unstable
Poor echocardiographic window
Conditions that would interfere with adherence to study requirements (e.g., ongoing alcohol or substance abuse)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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