ClinicalTrials.gg
Active, not recruitingNCT03324529Updated Mar 5, 2026

Autonomic Modulation in Takotsubo Syndrome

An interventional study of Tako Breath in Takotsubo Syndrome, sponsored by NYU Langone Health. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Takotsubo Cardiomyopathy with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Takotsubo Cardiomyopathy · United States.

Started
2021
the only one that year
No phase
6 of 11
1 open now
Registered
6th of 11
by date
Lead sponsor
2 of 11
NYU Langone Health

Among the 11 studies in Takotsubo Cardiomyopathy with a site in United States, this one is the only one that started in 2021, is one of 6 with no phase, and was the 6th registered.

Takotsubo Cardiomyopathy

63 studies on the registry are indexed under Takotsubo Cardiomyopathy; 26 are open to participants now.

Browse Takotsubo Cardiomyopathy studies →

Open to participants now

3 of the 11 studies in Takotsubo Cardiomyopathy with a site in United States are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 23 Takotsubo Cardiomyopathy studies recruiting now, 19 (83%) set no upper age limit and none (0%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: 21 Years and older · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Takotsubo Syndrome
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pacemaker or defibrillator implanted
  • Evidence of autonomic neuropathy, alcohol or drug abuse or exposure to neurotoxins (chemotherapy).
  • Diabetes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceTako 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.

    Also known as: RESPeRATE

06

What researchers measure

Primary outcomes

  1. heart rate variability

    Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch

    Time frame: 10 Weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2021 (actual). Primary completion is estimated for Jun 2027, 68 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2017
First posted
Oct 27, 2017
StartActual
Oct 1, 2021
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03324529
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Oct 27, 2017
Start date
Oct 1, 2021
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Mar 5, 2026

Study contacts

Harmony Reynolds, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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