Autonomic Modulation in Takotsubo Syndrome

NCT03324529 | Active Not Recruiting FDA Device

• 1 other identifier: 17-00868
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Takotsubo Syndrome

Outcome Measures

Primary Outcomes (1)

• heart rate variability

  Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch

  10 Weeks

Study Arms (1)

Participants in the NYU takotsubo registry

EXPERIMENTAL

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

Device: Tako Breath

Interventions

Tako Breath DEVICE

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.

Also known as: RESPeRATE

Participants in the NYU takotsubo registry

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Harmony Reynolds, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 27, 2017
• Study Start: October 1, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)