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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores why individuals with Takotsubo Syndrome (TS), a heart condition often triggered by stress, experience it differently and how stress affects their recovery over a year. The main focus is on understanding how various stress factors influence the condition's outcomes. Participants will undergo a stress reactivity test, which measures the body's response to stress, to gather this information. Individuals recently diagnosed with TS who understand English may be suitable candidates for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance understanding and treatment of TS.

Will I have to stop taking my current medications?

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

What prior data suggests that the stress reactivity test is safe?

Research has shown that Takotsubo Syndrome (TTS), often triggered by emotional or physical stress, causes temporary weakness in the heart muscle. This trial focuses on a stress reactivity test. Although specific safety details for the test are not provided, the trial's classification as "Not Applicable" for a typical clinical phase suggests it might be non-invasive or observational.

Past studies on stress reactivity tests in TTS patients have reported no negative effects. The trial aims to understand how stress impacts people with TTS over time. By observing reactions rather than administering new medications, the procedure is likely safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the stress reactivity test for Takotsubo Syndrome because it aims to uncover how stress impacts heart function in those affected by this condition. Unlike other treatments that focus on managing symptoms or preventing recurrence, this test seeks to understand the underlying stress response mechanisms. By pinpointing how stress triggers the syndrome, this approach could lead to more targeted and effective interventions in the future, potentially improving outcomes for patients.

What evidence suggests that the stress reactivity test is effective for Takotsubo Syndrome?

Research has shown that Takotsubo Syndrome, often triggered by intense emotional or physical stress, presents symptoms similar to a heart attack. Studies have found that most patients with this condition exhibit a normal heartbeat upon hospital arrival, suggesting a strong link between stress and the onset of Takotsubo Syndrome. This trial's stress reactivity test aims to better understand how stress affects the heart in these situations. Identifying stress triggers and their impact on heart function could help predict outcomes and improve patient care. ^{2 6 7 8 9}

Who Is on the Research Team?

Elena Salmoirago-Blotcher, MD, PhD

Principal Investigator

The Miriam Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK430798/

Takotsubo Cardiomyopathy - StatPearls - NCBI Bookshelf - NIH Takotsubo cardiomyopathy presentation is similar to acute coronary syndrome. This disorder is frequently triggered by intense emotional or physical stress, for ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1406761

Clinical Features and Outcomes of Takotsubo (Stress) ... Results on electrocardiography on admission showed sinus rhythm in more than 90% of the patients with takotsubo cardiomyopathy, who had a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04325321

NCT04325321 | The Broken Heart Study II (BHS-II) To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event. Detailed Description. Newly ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.055854

Takotsubo Syndrome: Pathophysiology, Emerging ... Clinical features and outcomes of takotsubo (stress) cardiomyopathy. N Engl J Med. 2015;373:929–938. doi: 10.1056/NEJMoa1406761. Crossref.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7058348/

Stress Cardiomyopathy Diagnosis and Treatment Stress cardiomyopathy is an acute reversible heart failure syndrome initially believed to represent a benign condition due to its self-limiting clinical course.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8733363/

Takotsubo Syndrome: A Review of Presentation, Diagnosis ... Takotsubo Syndrome (TTS) is a condition of transient left ventricular dysfunction that is typically triggered by emotional or physical stress.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9999670/

Epidemiology, Pathophysiology, Diagnosis, and Principles ... Precipitating physical or emotional or mixed stressful events have been identified in two-thirds of takotsubo cardiomyopathy cases [17].

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352906722000392

Update of Takotsubo cardiomyopathy: Present experience ... This article aims to review the current situation of TTS, briefly summarize pathophysiological mechanisms, discuss various risk factors, propose a diagnostic ...

9. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2739417

GEIST Score for Risk Stratification for In-hospital ... The findings suggest that evaluation of 4 clinical and echocardiographic variables may identify patients with takotsubo syndrome who have a high risk for in- ...