Clinical trial NCT05994664: Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients
Official title: The Effects Of Heart Coherence Training On Patients With Vascular Ehlers-Danlos Syndrome (HEARTMATH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Ehlers-Danlos Syndrome
Keywords: Cardiovascular
Mental Health
Heart Rate Variability
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Southern Star Research
First posted: 2023-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial will have two parallel groups and randomization will be performed at a 1:1 allocation.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Mean Overall Systolic Blood Pressure
timeFrame: 3 Months
Secondary outcomes:
measure: Mean systolic blood pressure
timeFrame: 3 Month
measure: Mean Diastolic blood pressure
timeFrame: 3 Month
measure: Nocturnal systolic blood pressure
timeFrame: 3 Month
measure: Nocturnal Diastolic blood pressure
timeFrame: 3 Month
measure: Diurnal Systolic blood pressure
timeFrame: 3 Month
measure: Diurnal Diastolic blood pressure
timeFrame: 3 Month
measure: Daily Systolic blood pressure
timeFrame: 3 Month
measure: Daily Diastolic blood pressure
timeFrame: 3 Month
measure: Coherence Percentage
timeFrame: 3 Months
measure: Heart rate variability
timeFrame: 3 Months
measure: Mean Heart Rate
timeFrame: Measured at baseline and follow up visit (at 12 weeks)
measure: Nocturnal Heart Rate
timeFrame: Measured at baseline and follow up visit (at 12 weeks)
measure: Diurnal Heart Rate
timeFrame: Measured at baseline and follow up visit (at 12 weeks)
measure: Quality of Life Scale (QOLS) (ages 19-21 y)
timeFrame: 3 Months
measure: Pediatric Quality of Life Scale (PedsQL) scale scores
timeFrame: 3 Months
measure: GAD-7
timeFrame: 3 Months
measure: PSC
timeFrame: 3 Months
measure: PSC-Y
timeFrame: 3 Months
measure: PSC-Y Attention Subscale
timeFrame: 3 Months
measure: PSC-Y Internalizing Problems Subscale
timeFrame: 3 Months
measure: PSC-Y Externalizing Problems Subscale
timeFrame: 3 Months
measure: PROMIS Pediatric Self- Reported Psychological Stress
timeFrame: 3 Months
measure: PROMIS Parent Proxy Reported Psychological Stress- Parent Proxy
timeFrame: 3 Months
measure: The PROMIS Adult Depression SF v1.0 8a
timeFrame: 3 Months
measure: The PROMIS Pediatric Depression SF V2.0 8a
timeFrame: 3 Months
measure: The PROMIS Parent Proxy Depression SF v2.0 6a
timeFrame: 3 Months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Shaine A Morris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: