Autonomic Modulation in Takotsubo Syndrome

Last updated: March 25, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Cardiomyopathy

Congestive Heart Failure

Treatment

Tako Breath

Clinical Study ID

NCT03324529
17-00868
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed history of takotsubo syndrome

  • Healthy person with no significant past history of cardiovascular or neurologicaldisease such as heart failure or heart attack; people with cardiovascular riskfactors such as hypertension will be permitted to participate

Exclusion

Exclusion Criteria:

  • Pacemaker or defibrillator implanted

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

  • Diabetes

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Tako Breath
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • New York University School of Medicine

    New York, New York 10016
    United States

    Active - Recruiting

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