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Behavioural Intervention
Tako Breath for Takotsubo Syndrome
N/A
Recruiting
Led By Harmony Reynolds, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed history of takotsubo syndrome
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study Summary
This trial will study whether a device-guided breathing program can improve autonomic measures and quality of life in patients with takotsubo.
Who is the study for?
This trial is for individuals who have had Takotsubo syndrome, a heart condition often called 'broken heart syndrome,' and healthy people without major cardiovascular or neurological issues. Those with hypertension may join, but not those with pacemakers, autonomic neuropathy, substance abuse problems, diabetes, or exposure to neurotoxins like chemotherapy.Check my eligibility
What is being tested?
The study tests 'Tako Breath,' a device-guided breathing program designed to improve the body's autonomic functions—how it controls heart rate and stress responses. Participants will do this for 15 weeks while their autonomic function is monitored both in-lab and remotely at home.See study design
What are the potential side effects?
Since the intervention involves guided breathing exercises using a device (Tako Breath), side effects are expected to be minimal. However, specific side effects aren't detailed as this is more of an observational study on how these exercises affect the nervous system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with takotsubo syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
heart rate variability
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants in the NYU takotsubo registryExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,611 Total Patients Enrolled
Harmony Reynolds, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with takotsubo syndrome.I am healthy with no major heart or brain disease history, though I may have high blood pressure.I have nerve damage, a history of substance abuse, or exposure to harmful chemicals.I have diabetes.You have a pacemaker or defibrillator implanted.
Research Study Groups:
This trial has the following groups:- Group 1: Participants in the NYU takotsubo registry
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still enrolling participants in this experiment?
"Clinicaltrials.gov states that this trial is presently recruiting participants, with the original posting being on October 1st 2021 and the latest update occurring on June 14th 2022."
Answered by AI
How many individuals are taking part in this research project?
"Affirmative. According to clinicaltrials.gov, this research project was initially posted on October 1st 2021 and has been actively seeking participants since its last edit made on June 14th 2022. Currently, the experiment is searching for 24 individuals across a single site."
Answered by AI
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