Autonomic Modulation in Takotsubo Syndrome

Not Applicable

Recruiting

• Conditions: Takotsubo Syndrome
• Interventions: Device: Tako Breath

• Registration Number: NCT03324529
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-27
• Study Start: 2021-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants in the NYU takotsubo registry	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

Primary Outcome Measures

Name	Time	Method
heart rate variability	10 Weeks	Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States