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

Takotsubo Cardiomyopathy Clinical Trial

Official title: Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Takotsubo Cardiomyopathy

• NCT number: NCT04325321
• Study type: Interventional
• Source: The Miriam Hospital
• Contact: Elena Salmoirago-Blotcher, MD, PhD
• Phone: 401-793-8325
• Email: Elena_Salmoirago-Blotcher@brown.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2020
• Completion date: December 31, 2024