Takotsubo Syndrome
Conditions
Brief summary
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.
Interventions
DEVICETako Breath
Device guided breathing. A medical device with a computerized control unit, a breathing sensor and a set of earphones with audio-prompts to guide breathing at a slow rate (\<10 breaths/min) with prolonged exhalation.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| heart rate variability | 10 Weeks | Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHarmony Reynolds, MD
NYU Langone Health
Outcome results
None listed