The Broken Heart Study II (BHS-II) (BHS)
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|ClinicalTrials.gov Identifier: NCT04325321|
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : January 5, 2022
The goals of this study are as follows:
- To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS).
- To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event.
|Condition or disease||Intervention/treatment||Phase|
|Takotsubo Cardiomyopathy||Other: Stress reactivity test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome|
|Actual Study Start Date :||September 2, 2020|
|Estimated Primary Completion Date :||November 30, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Stress reactivity test
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.
- Mean change (in pg/mL) in plasma epinephrine levels [ Time Frame: 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 [ Time Frame: 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.
- Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square) [ Time Frame: 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.
- Left ventricular ejection fraction (%) [ Time Frame: 12 months ]A trans-thoracic echocardiogram will be performed with computation of ejection fraction according to current guidelines.
- Average Global Longitudinal Strain (GLS) [ Time Frame: 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.
- Proportion of patients with major adverse cardiac and cerebrovascular events [ Time Frame: 12 months ]Composite of death from any cause, recurrence of TS, stroke, transient ischemic attack, and myocardial infarction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325321
|Contact: Elena Salmoirago-Blotcher, MD, PhD||401-793-8325 ext 38325||Elena_Salmoirago-Blotcher@brown.edu|
|United States, Rhode Island|
|The Miriam Hospital||Recruiting|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Elena Salmoirago-Blotcher, MD, PhD||The Miriam Hospital|