Autonomic Modulation in Takotsubo Syndrome

NCT ID: NCT03324529

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Takotsubo Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Tako Breath

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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RESPeRATE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harmony Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Harmony Reynolds

Role: CONTACT

646-501-0302

Facility Contacts

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Harmony Reynolds

Role: primary

646-501-0302

Other Identifiers

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17-00868

Identifier Type: -

Identifier Source: org_study_id

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