Autonomic Modulation in Takotsubo Syndrome

NCT03324529 — Not applicable, Active not recruiting, 24 participants, NYU Langone Health

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT03324529
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	NYU Langone Health (Other)
Conditions	Takotsubo Syndrome
Interventions	Tako Breath (Device)
Dates	start 2021-10-01, primary completion 2027-06-01 (estimated), completion 2027-06-01 (estimated), first posted 2017-10-27, last updated 2026-03-05
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Participants in the NYU takotsubo registry	Experimental	Device: Tako Breath	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

Tako Breath (Device), also known as RESPeRATE: 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.

+Outcome measures

Primary outcomes

heart rate variability [10 Weeks]: Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch

+Eligibility

Sex: All, ages: 21 Years to any

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

+Locations (1)

Facility	City	Country	Status
New York University School of Medicine	New York, New York	United States

+Investigators

Harmony Reynolds, MD, Principal investigator, NYU Langone Health

My Notes

Public

To Read Reading Read