Breathing device program for patients with Takotsubo Syndrome
Autonomic Modulation in Takotsubo Syndrome
This study is testing whether a breathing device can help improve the quality of life and autonomic function for people who have had Takotsubo Syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03324529 on ClinicalTrials.gov |
What this trial studies
This study involves a case-controlled intervention with 10 patients who have a history of Takotsubo Syndrome and 10 matched healthy controls. Participants will undergo laboratory testing to assess autonomic function, followed by a 15-week program utilizing a breathing device designed to improve autonomic measures. Remote monitoring will track autonomic function at home, and the study aims to evaluate the reproducibility of these measures and the potential impact of device-guided breathing on quality of life for patients with Takotsubo Syndrome.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed history of Takotsubo Syndrome.
Not a fit: Patients with implanted pacemakers or defibrillators, evidence of autonomic neuropathy, or significant past cardiovascular or neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of Takotsubo Syndrome through improved autonomic function and quality of life.
How similar studies have performed: While this approach is innovative, there is limited data on similar studies specifically targeting Takotsubo Syndrome with device-guided breathing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- New York University School of Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Harmony Reynolds, MD — NYU Langone Health
- Study coordinator: Harmony Reynolds
- Email: brokenheartstudy@nyumc.org
- Phone: 646-501-0302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.