Skip to main content
OpenTrials
Completed

NCT Number: NCT04325321

The Broken Heart Study II (BHS-II)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Takotsubo Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress reactivity test

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Left ventricular ejection fraction (%)

    Time frame: 12 months

    A trans-thoracic echocardiogram will be performed with computation of ejection fraction according to current guidelines.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome

Acronym: BHS

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Mar 27, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.