Clinical trial NCT04325321: The Broken Heart Study II (BHS-II)
Official title: Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Takotsubo Cardiomyopathy
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-03-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change (in pg/mL) in plasma epinephrine levels
timeFrame: Up to 4 weeks
measure: Mean change (in pg/mL) in plasma norepinephrine levels
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square)
timeFrame: Up to 4 weeks
measure: Left ventricular ejection fraction (%)
timeFrame: 12 months
measure: Average Global Longitudinal Strain (GLS)
timeFrame: 12 months
Other outcomes:
measure: Proportion of patients with major adverse cardiac and cerebrovascular events
timeFrame: 12 months
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Elena Salmoirago-Blotcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: