Stress Reactivity Test for Takotsubo Syndrome

(BHS Trial)

Overseen By Elena Salmoirago-Blotcher, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Uncontrolled hypertension, Acute psychosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Stress Reactivity Test for Takotsubo Syndrome safe for humans?

The Stress Reactivity Test, which can include stress testing like dobutamine stress echocardiography, has been associated with rare cases of Takotsubo syndrome, a temporary heart condition. While generally safe, it is important for medical professionals to be aware of this potential complication during and after the test. ^{1 2 3 4 5}

How does the Stress Reactivity Test treatment differ from other treatments for Takotsubo Syndrome?

The Stress Reactivity Test for Takotsubo Syndrome is unique because it focuses on understanding the body's response to stress, which is a key trigger for this condition. Unlike other treatments that may address symptoms or complications, this approach aims to identify and manage the stress-related mechanisms that contribute to the syndrome. ^{2 6 7 8 9}

Research Team

Elena Salmoirago-Blotcher, MD, PhD

Principal Investigator

The Miriam Hospital

Eligibility Criteria

The Broken Heart Study II is for adults over 18 with a new diagnosis of Takotsubo Syndrome, who can understand and speak English. It's not suitable for those unable to consent, with severe cognitive issues, uncontrolled high blood pressure, acute psychosis, high suicide risk, pregnancy or poor heart imaging quality.

Inclusion Criteria

I have been newly diagnosed with takotsubo syndrome.

Exclusion Criteria

You are at high risk of wanting to harm yourself.

If the participant is clinically unstable

You are currently experiencing severe mental confusion or hallucinations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Clinically stable patients undergo an in-person comprehensive interview and complete a battery of psychosocial questionnaires

2-4 weeks after discharge

1 visit (in-person)

Laboratory Stress Protocol

Participants undergo a validated laboratory stress protocol to assess autonomic nervous system activity

Single session

1 visit (in-person)

Follow-up

Echocardiographic evaluations and assessment of major adverse cerebrovascular events

12 months

1 visit (in-person)

Treatment Details

Interventions

• Stress reactivity test

Trial Overview This study investigates the underlying causes of Takotsubo Syndrome (a stress-induced cardiomyopathy) and how stress events affect patients' health one year after diagnosis. Participants will undergo a stress reactivity test as part of the research.

Participant Groups

Group I: Stress reactivity Experimental Treatment 1 Intervention

Stress reactivity test

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

This case report highlights a unique instance of Takotsubo syndrome occurring shortly after childbirth, alongside HELLP syndrome, demonstrating that emotional and physical stressors can trigger this condition even in the absence of typical cardiac symptoms.

The study emphasizes the value of measuring cardiac biomarkers like troponin I and NT-proBNP, which can aid in diagnosing Takotsubo syndrome, complementing non-invasive imaging techniques such as echocardiography and MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inverted Takotsubo Syndrome With HELLP Syndrome: A Case Report. Gabarre, P., Ruiz, P., Chenevier-Gobeaux, C., et al.[2022]

During the Covid-19 pandemic, five hospitalized patients with severe SARS-CoV-2 infection developed Takotsubo syndrome, highlighting a potential cardiac complication associated with the virus.

Early identification of Takotsubo syndrome is crucial, as it can be suspected through echocardiography when patients show abnormal electrocardiograms, elevated troponin levels, or clinical deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Takotsubo syndrome in COVID-19: a case series study. Arroyo-Rodríguez, C., Victoria-Nandayapa, JR., López-Aceves, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Delayed-Type Hypersensitivity to Metals of Environmental Burden in Patients with Takotsubo Syndrome - Is There a Clinical Relevance? [2018]

2. England pubmed.ncbi.nlm.nih.gov

Triggers, characteristics, and hospital outcome of patients with Takotsubo syndrome: 10 years experience in a large university hospital centre. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Takotsubo (apical ballooning) syndrome in the recovery period following dobutamine stress echocardiography: a first report. [2011]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Case report: Changes in the levels of stress hormones during Takotsubo syndrome. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Inverted Takotsubo Syndrome With HELLP Syndrome: A Case Report. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Autonomic Findings in Takotsubo Cardiomyopathy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Takotsubo syndrome (stress cardiomyopathy): an intriguing clinical condition in search of its identity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A life-threatening reverse Takotsubo syndrome in a young breastfeeding woman: a case report. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Takotsubo syndrome in COVID-19: a case series study. [2022]