Health TrialsbyHealthPanel

Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

ConditionVascular Ehlers-Danlos Syndrome
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Heartmath Intervention

    Other intervention

    The participants will all complete baseline surveys and paperwork including signed consent, psychometric surveys, demographic survey, and a brief, open-ended questionnaire about their feelings about living with VEDS. During the initial visit for the intervention group the same assessment will be included, however, they will also receive 10-15 of instruction on a basic Heartmath technique. Group participants will be asked to complete 5-10 minutes of HeartMath techniques 2x daily. Participants from both groups will have weekly virtual sessions that include the 3-step Protocol HRV assessment. However, each week the intervention group will receive an addition 10-15 minutes of training and advancement on HeartMath techniques as well as continued written and video reinforcement.

  • Control Group

    Other intervention

    The participants will all complete baseline surveys and paperwork including signed consent, psychometric surveys, demographic survey, and a brief, open-ended questionnaire about their feelings about living with VEDS. The initial visit will include an HRV assessment using the HeartMath sensor via the 3-step Protocol developed by the HeartMath Institute. Participants from both groups 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 groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change in Mean Overall Systolic Blood Pressure

Comparing baseline to post-intervention overall systolic blood pressure in percent

Time frame
3 Months

Secondary outcomes

1

Mean systolic blood pressure

mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile

Time frame
3 Month
2

Mean Diastolic blood pressure

mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile

Time frame
3 Month
3

Nocturnal systolic blood pressure

mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, nocturnal reading

Time frame
3 Month
4

Nocturnal Diastolic blood pressure

mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, nocturnal reading

Time frame
3 Month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Southern Star Research

Collaborator

Source ClinicalTrials.gov
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