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Autonomic Modulation in Takotsubo Syndrome

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ClinicalTrials.gov Identifier: NCT03324529
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Takotsubo Syndrome Device: Tako Breath Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autonomic Modulation in Takotsubo Syndrome
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants in the NYU takotsubo registry

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
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.
Other Name: RESPeRATE


Outcome Measures
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Primary Outcome Measures :
  1. heart rate variability [ Time Frame: 10 Weeks ]
    Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324529


Contacts
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Contact: Harmony Reynolds 646-501-0302 brokenheartstudy@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Harmony Reynolds    646-501-0302    harmony.reynolds@nyumc.org   
Principal Investigator: Harmony Reynolds, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Harmony Reynolds, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03324529    
Other Study ID Numbers: 17-00868
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Takotsubo Cardiomyopathy
Syndrome
Disease
Pathologic Processes
 Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases