The Broken Heart Study II (BHS-II)

Lifespan

Status: Active, not recruiting

Conditions: Takotsubo Cardiomyopathy

Treatments: Other: Stress reactivity test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04325321

R01HL149672 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Pregnancy
• Poor echocardiographic window
• Conditions that would interfere with adherence to study requirements (e.g., ongoing alcohol or substance abuse)
• If the participant is clinically unstable

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Stress reactivity

Other group

Description:

Stress reactivity test

Treatment:

Other: Stress reactivity test