RECRUITING

Autonomic Modulation in Takotsubo Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Autonomic Modulation in Takotsubo Syndrome

Quick Facts

Study Start:2021-10-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03324529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed history of takotsubo syndrome
  2. * 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
  1. * Pacemaker or defibrillator implanted
  2. * Evidence of autonomic neuropathy, alcohol or drug abuse or exposure to neurotoxins (chemotherapy).
  3. * Diabetes

Contacts and Locations

Study Contact

Harmony Reynolds
CONTACT
646-501-0302
brokenheartstudy@nyumc.org

Principal Investigator

Harmony Reynolds, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

New York University School of Medicine
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Harmony Reynolds, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2021-10-01
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Takotsubo Syndrome