Autonomic Modulation in Takotsubo Syndrome

Takotsubo Syndrome Clinical Trial

Official title:

Autonomic Modulation in Takotsubo Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03324529
• Other study ID #: 17-00868
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Harmony Reynolds
• Phone: 646-501-0302
• Email: brokenheartstudy[@]nyumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Takotsubo Cardiomyopathy
• Takotsubo Syndrome

Intervention

Device:
• Tako 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate variability	Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch	10 Weeks