Autonomic Modulation in Takotsubo Syndrome

NYU Langone Health

Status: Enrolling

Conditions: Takotsubo Syndrome

Treatments: Device: Tako Breath

Study type: Interventional

Funder types: Other

Identifiers

NCT03324529

17-00868

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed history of takotsubo syndrome
• Healthy person with no significant past history of cardiovascular or neurological disease such as heart failure or heart attack; people with cardiovascular risk factors such as hypertension will be permitted to participate

Exclusion criteria

• Pacemaker or defibrillator implanted
• Evidence of autonomic neuropathy, alcohol or drug abuse or exposure to neurotoxins (chemotherapy).
• Diabetes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Participants in the NYU takotsubo registry

Experimental group

Description:

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

Treatment:

Device: Tako Breath