Tako Breath for Takotsubo Syndrome

Overseen By Harmony Reynolds

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pacemaker, Defibrillator, Autonomic neuropathy, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a minimal risk case-controlled single arm intervention study, including 10 patients with a prior history of takotsubo and 10-age and sex matched healthy controls. Subjects will undergo in laboratory testing to measure autonomic function. They will then undergo a 15-week program of device-guided breathing with remote measures of autonomic function obtained at home. Analysis will determine the reproducibility of home autonomic measures and the provide preliminary data to determine the efficacy of device-guided breathing on autonomic measures and quality of life in patients with takotsubo.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the Tako Breath treatment different from other treatments for Takotsubo Syndrome?

Tako Breath is unique because it uses device-guided breathing therapy, which focuses on controlling breathing to manage stress, a common trigger for Takotsubo Syndrome. Unlike other treatments that may involve medication or invasive procedures, this approach is non-invasive and aims to address the mind-body connection by reducing stress through controlled breathing. ^{1 2 3 4 5}

Research Team

Harmony Reynolds, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals who have had Takotsubo syndrome, a heart condition often called 'broken heart syndrome,' and healthy people without major cardiovascular or neurological issues. Those with hypertension may join, but not those with pacemakers, autonomic neuropathy, substance abuse problems, diabetes, or exposure to neurotoxins like chemotherapy.

Inclusion Criteria

I have been diagnosed with takotsubo syndrome.

I am healthy with no major heart or brain disease history, though I may have high blood pressure.

Exclusion Criteria

I have nerve damage, a history of substance abuse, or exposure to harmful chemicals.

I have diabetes.

You have a pacemaker or defibrillator implanted.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-laboratory Testing

Subjects undergo in-laboratory testing to measure autonomic function

1 week

1 visit (in-person)

Device-guided Breathing Program

Participants undergo a 15-week program of device-guided breathing with remote measures of autonomic function obtained at home

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tako Breath

Trial Overview The study tests 'Tako Breath,' a device-guided breathing program designed to improve the body's autonomic functions—how it controls heart rate and stress responses. Participants will do this for 15 weeks while their autonomic function is monitored both in-lab and remotely at home.

Participant Groups

Group I: Participants in the NYU takotsubo registry Experimental Treatment 1 Intervention

10 patients with a confirmed history of takotsubo syndrome 10 age- and sex-matched healthy controls with no significant history of cardiac or neurological illness

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

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]

Takotsubo disease, also known as 'broken-heart syndrome', is a serious condition that can be life-threatening and is often triggered by sudden psychological or physical stress.

Patients with Takotsubo disease typically experience severe heart failure, necessitating advanced medical support in a specialized Cardiovascular Care Unit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Takotsubo cardiomyopathy: The mind-body continuum]. Carísimo, E., Fantacone, N., Fadel, D.[2018]

Takotsubo syndrome (TTS) can occur after percutaneous coronary intervention (PCI), presenting symptoms similar to PCI complications, such as ST segment elevation and troponin elevation, highlighting the need for careful diagnosis.

Medical professionals should be aware of the psychological and emotional stress factors that can contribute to TTS and provide comprehensive support to patients during the perioperative period to mitigate these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Takotsubo syndrome following percutaneous coronary intervention. Lu, R., Lu, M., He, S., et al.[2023]

This consensus paper highlights the importance of recognizing biomarkers, particularly excess catecholamines, and specific electrocardiographic changes in diagnosing and managing takotsubo syndrome (TTS), based on a multinational collaboration.

It introduces new structured algorithms to assist clinicians in decision-making and emphasizes the need for further research into the genetics, microRNAs, and imaging techniques related to TTS, addressing the current gaps in evidence-based medical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Takotsubo syndrome: State-of-the-art review by an expert panel - Part 2. Dias, A., Núñez Gil, IJ., Santoro, F., et al.[2021]

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. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. Argentina pubmed.ncbi.nlm.nih.gov

[Takotsubo cardiomyopathy: The mind-body continuum]. [2018]

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

Case report: Takotsubo syndrome following percutaneous coronary intervention. [2023]

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

Takotsubo syndrome: State-of-the-art review by an expert panel - Part 2. [2021]

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

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