Autonomic Modulation in Takotsubo Syndrome

Brief Title

Autonomic Modulation in Takotsubo Syndrome

Official Title

Autonomic Modulation in Takotsubo Syndrome

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.
    



Study Type

Interventional


Primary Outcome

heart rate variability


Condition

Takotsubo Syndrome

Intervention

Tako Breath

Study Arms / Comparison Groups

 Participants in the NYU takotsubo registry
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

24

Start Date

September 2020

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        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
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Harmony Reynolds, MD, 646-501-0302, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03324529

Organization ID

17-00868


Responsible Party

Sponsor

Study Sponsor

NYU Langone Health


Study Sponsor

Harmony Reynolds, MD, Principal Investigator, NYU Langone Health


Verification Date

May 2020