The Broken Heart Study II (BHS-II) (BHS)
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- STATUS
- Recruiting
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- End date
- Dec 31, 2024
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- participants needed
- 106
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- sponsor
- The Miriam Hospital
Summary
The goals of this study are as follows:
- To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS).
- 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=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.
Details
| Condition | Takotsubo Cardiomyopathy |
|---|---|
| Treatment | Stress reactivity test |
| Clinical Study Identifier | NCT04325321 |
| Sponsor | The Miriam Hospital |
| Last Modified on | 7 April 2023 |
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