Back to resultsAutonomic Modulation in Takotsubo Syndrome
Primary Purpose
Takotsubo Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tako Breath
Sponsored by
About this trial
This is an interventional treatment trial for Takotsubo Syndrome
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
Sites / Locations
- New York University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants in the NYU takotsubo registry
Arm 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
Outcomes
Primary Outcome Measures
heart rate variability
Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03324529
Brief Title
Autonomic Modulation in Takotsubo Syndrome
Official Title
Autonomic Modulation in Takotsubo Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takotsubo Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants in the NYU takotsubo registry
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Tako Breath
Other Intervention Name(s)
RESPeRATE
Intervention Description
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.
Primary Outcome Measure Information:
Title
heart rate variability
Description
Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch
Time Frame
10 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harmony Reynolds
Phone
646-501-0302
Email
brokenheartstudy@nyumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmony Reynolds, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harmony Reynolds
Phone
646-501-0302
Email
harmony.reynolds@nyumc.org
First Name & Middle Initial & Last Name & Degree
Harmony Reynolds, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Autonomic Modulation in Takotsubo Syndrome
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