The Broken Heart Study II (BHS-II)
- Conditions
- Takotsubo Cardiomyopathy
- Interventions
- Other: Stress reactivity test
- Registration Number
- NCT04325321
- Lead Sponsor
- The Miriam Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 66
- Age >=18
- A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
- Ability to understand and speak English
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stress reactivity Stress reactivity test Stress reactivity test
- Primary Outcome Measures
Name Time Method Mean change (in pg/mL) in plasma epinephrine levels Up to 4 weeks Blood samples for plasma epinephrine are collected 10-min into Baseline, 10-min into Emotion Recall, and 18 minutes into Recovery Phase. Change will be calculated by subtracting Baseline epinephrine levels from Emotion Recall levels.
Mean change (in pg/mL) in plasma norepinephrine levels Up to 4 weeks Blood samples for plasma norepinephrine are collected 10-min into Baseline, 10-min into Emotion Recall, and 18 minutes into Recovery Phase. Change will be calculated by subtracting Baseline epinephrine levels from Emotion Recall norepinephrine levels.
- Secondary Outcome Measures
Name Time Method Average Global Longitudinal Strain (GLS) 12 months Global Longitudinal Strain (GLS) will be assessed using off-line analysis software (TomTec imaging systems). GLS will be calculated as the average left ventricular longitudinal strain across the segments obtained using apical two, three, and four-chamber views. Because myocardial contraction results in left ventricular shortening in systole, GLS is a negative value.
Left ventricular ejection fraction (%) 12 months A trans-thoracic echocardiogram will be performed with computation of ejection fraction according to current guidelines.
Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square) Up to 4 weeks High frequency power heart rate variability (hf-HRV) will be determined by averaging high frequency values for 4-min segments within each phase (Baseline, Emotion Recall), and change will be calculated (Emotion Recall minus Baseline). Data will be collected using a Digital Holter ECG Recorder - 5 Lead, 2 Channel.
Trial Locations
- Locations (1)
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States