Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-45
SponsorBaylor College of Medicine

About this trial

Vascular Ehlers-Danlos Syndrome (VEDS) is caused by pathogenic variants of the COL3A1 gene, resulting abnormal Type III collagen protein. This impacts the body's connective tissue and makes people with VEDS at high risk of spontaneous aortic and arterial rupture, pneumothorax, and hollow organ perforation across the age spectrum. Given this risk and high potential for lethality, VEDS is considered the most severe type of Ehlers-Danlos Syndrome. In addition, many patients experience chronic pain and fatigue, sleep disturbances, and mental health challenges. As is the case for many patients with chronic illness, stress, anxiety, and depression are often present over the course of the disease. Despite the antecedent, stress and anxiety trigger a sympathetic nervous system (SNS) response in the body, which, over a period of time, can have detrimental effects both physiologically and psychologically for patients. Recent studies have begun to use biofeedback techniques to teach patients non-pharmacological strategies for managing their autonomic nervous system. One such program, Heartmath®, has been successful in helping patients lower stress, anxiety, and systolic blood pressure. This pilot trial was established to assess the effectiveness of a virtually based heart coherence program in a population with a chronic aortopathy in an effort to establish a larger, multi-provider program that also encompasses other cardiovascular populations.

Eligibility criteria

Qualifiers

Participants must be diagnosed with Vascular Ehlers-Danlos Syndrome verified by a mutation of the COL3A1 gene

Ages 12-45 year at the time of enrollment

Access to a smartphone as well as an additional device with camera and microphone

Stable internet access

Disqualifiers

Non-English speakers

Any conditions or developmental delays limiting the ability to utilize technology or follow directions.

Trial design

Treatments tested in this trial

  • Heartmath Intervention
  • Control Group

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Baylor College of Medicine

Lead sponsor

Southern Star Research

Collaborator