Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

Baylor College of Medicine

Status: Enrolling

Conditions: Vascular Ehlers-Danlos Syndrome

Treatments: Other: Heartmath Intervention; Other: Control Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05994664

H-53424

Details and patient eligibility

About

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.

Full description

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. For patients with already compromised cardiovascular systems, the dysregulation of their nervous system can potentially be detrimental to their mental and physiological health, as well as their overall quality of life.

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.

Our primary aim of this study is to evaluate the effects of an 8 week, virtually-based heart coherence training program (HCTP) with the use of wearable, biofeedback technology. The goal is to perform a randomized-controlled pilot study to assess effect estimates on multiple outcomes in an effort to establish a foundation for a larger, longitudinal trial.

The objective is to:

1. Randomize 20 patients with Vascular Ehlers-Danlos Syndrome from ages 12 -45 years to current status and care (controls) versus a biofeedback intervention of additional training and advancement on HeartMath techniques, then
2. Allow the control group subjects to then have access to materials related to the techniques that were taught to the HMI group to allow for therapeutic equality. The investigators will then compare outcomes between both the intervention and control groups, and between the baseline and post-intervention states. Specific outcome measures will include ambulatory blood pressure, heart rate variability, coherence ratio, mean heart rate, quality of life/mental health assessment: health-related quality of life, depression and anxiety screening scales.

Our hypothesis is that individuals with VEDS undergoing a supervised HCTP will demonstrate improvements in ambulatory blood pressure, heart rate variability, and mental health survey measures.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• English speaking

Exclusion criteria

• Non-English speakers
• Any conditions or developmental delays limiting the ability to utilize technology or follow directions.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Group of up to 20 patients will be randomly allocated into an experimental group at a 1:1 ratio intervention to controls. The experimental group will receive all of the preliminary outcome screening with the additional 10-15 minutes of training and advancement on HeartMath techniques as well as continued written and video reinforcement.

Treatment:

Other: Heartmath Intervention

Control

Placebo Comparator group

Description:

Group of up to 20 patients will be randomly allocated into a control group at a 1:1 ratio for intervention to controls. The control group will receive all of the preliminary outcome screening and will have weekly virtual sessions that include the 3-step Protocol HRV assessment. After the CG has completed 8 weeks, they will then have access to materials related to the techniques that were taught to the HMI group to allow for therapeutic equality.

Treatment:

Other: Control Group