The Broken Heart Study II (BHS-II)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    246
  • sponsor
    The Miriam Hospital
Updated on 27 January 2021

Summary

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.

Description

Newly admitted patients with a validated diagnosis of Takotsubo Syndrome (TS; n=246) 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.

Details
Condition Takotsubo Syndrome
Treatment Stress reactivity test
Clinical Study IdentifierNCT04325321
SponsorThe Miriam Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Takotsubo Syndrome?
Do you have any of these conditions: Do you have Takotsubo Syndrome??
Do you have any of these conditions: Do you have Takotsubo Syndrome??
Do you have any of these conditions: Do you have Takotsubo Syndrome??
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
Pregnancy
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

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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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