The Broken Heart Study II (BHS-II)

Takotsubo Cardiomyopathy Clinical Trial

— BHS  

Official title:

Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325321
• Other study ID #: R01HL149672
• Secondary ID: R01HL149672
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: The Miriam Hospital
• Contact: Elena Salmoirago-Blotcher, MD, PhD
• Phone: 401-793-8325
• Email: Elena_Salmoirago-Blotcher[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Takotsubo Cardiomyopathy

Intervention

Other:
• Stress reactivity test
The protocol consists of Resting Baseline (BL), Emotion Recall (ER), followed by a Recovery Phase (RP). Heart rate and blood pressure are measured at baseline and then every 5 minutes during ER and RP. Resting Baseline (BL - 10 min). The participant is instructed to rest quietly. Emotion Recall (ER - 5-10 min). The participant is instructed to think about the incident associated with the onset of their cardiac event and bring to mind details of the incident. When the participants have the incident clearly in mind, they are instructed to relate the incident and their experience out loud; frequent questions to re-elicit the emotion are asked. Recovery Phase (RP - 20 min). Upon completion of RP, the catheter is removed and participants are de-instrumented. Blood samples for plasma catecholamines, assessments of heart rate variability, and echocardiograms are performed 10-min into BL, 10-min into ER, and 18 minutes into RP.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients with major adverse cardiac and cerebrovascular events	Composite of death from any cause, recurrence of TS, stroke, transient ischemic attack, and myocardial infarction.	12 months
Primary	Mean change (in pg/mL) in plasma epinephrine levels	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.	Up to 4 weeks
Primary	Mean change (in pg/mL) in plasma norepinephrine levels	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.	Up to 4 weeks
Secondary	Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square)	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.	Up to 4 weeks
Secondary	Left ventricular ejection fraction (%)	A trans-thoracic echocardiogram will be performed with computation of ejection fraction according to current guidelines.	12 months
Secondary	Average Global Longitudinal Strain (GLS)	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.	12 months