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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new breathing technique called Tako Breath to assist individuals with takotsubo syndrome, a condition where stress leads to heart problems. Researchers aim to determine if this breathing method can enhance nervous system function and overall quality of life for those affected. The trial includes both individuals with a history of takotsubo syndrome and healthy participants. Ideal candidates are those with a confirmed history of takotsubo syndrome or healthy individuals without significant heart or nerve issues. As an unphased trial, this study provides participants the chance to contribute to innovative research that could improve treatment options for takotsubo syndrome.

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.

What prior data suggests that this device-guided breathing therapy is safe for autonomic function testing?

Research shows that the Tako Breath treatment poses minimal risk, meaning it is unlikely to cause harm. It involves a program of device-guided breathing, a non-invasive method. Studies have not shown significant side effects from this type of breathing, suggesting it is well-tolerated by participants.

The trial aims to examine how breathing affects the body's automatic functions, such as heart rate. Since the study focuses on the treatment's effects rather than safety testing, the treatment is already considered safe enough for people to try. Overall, participants can feel reassured about the low-risk nature of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Takotsubo Syndrome, which typically focus on managing symptoms with medications like beta-blockers and ACE inhibitors, Tako Breath introduces a novel approach. Researchers are excited about Tako Breath because it explores a new mechanism of action that targets the underlying causes of stress-induced cardiomyopathy directly. This treatment is unique in its potential to address both cardiac and neurological aspects of the condition, offering a more comprehensive intervention than current symptom-focused therapies.

What evidence suggests that device-guided breathing is effective for takotsubo syndrome?

This trial will evaluate the Tako Breath device, which guides breathing to potentially improve nervous system control of automatic actions in people with Takotsubo syndrome. This condition, often triggered by stress, affects the heart. Early findings suggest that deep breathing exercises can help stabilize heart rate and reduce stress levels, both crucial for managing this syndrome. While researchers continue to gather specific evidence for Takotsubo syndrome, the basic idea is that calming the nervous system through these exercises could provide some relief. ^{1 2 3 4 5}

Who Is on the Research Team?

Harmony Reynolds, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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

I have been diagnosed with takotsubo syndrome.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-syndrome-6-2020-07b3b

Tako Breath for Takotsubo Syndrome 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 ...

2. med.nyu.edu med.nyu.edu/departments-institutes/medicine/divisions/cardiology/research/clinical-trials/takotsubo-syndrome-registry-clinical-studies/about-the-clinical-studies

Takotsubo Syndrome Clinical Studies | NYU Langone Health Our upcoming Takotsubo syndrome clinical study aims to determine whether deep breathing is beneficial in people who have been diagnosed with the condition.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03324529

Autonomic Modulation in Takotsubo Syndrome Analysis will determine the reproducibility of home autonomic measures and the provide preliminary data to determine the efficacy of device-guided breathing on ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03324529/autonomic-modulation-in-takotsubo-syndrome

Autonomic Modulation in Takotsubo Syndrome This is a minimal risk case-controlled single arm intervention study, including 10 patients with a prior history of takotsubo and 10-age and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8913320/

Update of Takotsubo cardiomyopathy: Present experience ... Differences in the Clinical Profile and Outcomes of Typical and Atypical Takotsubo Syndrome: Data From the International Takotsubo Registry.