Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

NCT05994664 | Recruiting

• 1 other identifier: H-53424
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Ehlers-Danlos Syndrome

Keywords

Cardiovascular; Mental Health; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• Percent Change in Mean Overall Systolic Blood Pressure

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

  3 Months

Secondary Outcomes (26)

• Mean systolic blood pressure

  3 Month

• Mean Diastolic blood pressure

  3 Month

• Nocturnal systolic blood pressure

  3 Month

• Nocturnal Diastolic blood pressure

  3 Month

• Diurnal Systolic blood pressure

  3 Month

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Heartmath Intervention

Control

PLACEBO COMPARATOR

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.

Other: Control Group

Interventions

Heartmath Intervention OTHER

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.

Intervention

Control Group OTHER

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.

Control

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Southern Star Research: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos Syndrome, Type IV; Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Ehlers-Danlos Syndrome; Hemostatic Disorders; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shaine A Morris, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaine A Morris, MD, MPH

CONTACT

832-826-5692; shainem@bcm.edu

Jennifer Bogardus, PT, MPT, PhD

CONTACT

713-794-2070; jennifer.bogardus@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics-Cardiology

Model Details: Trial will have two parallel groups and randomization will be performed at a 1:1 allocation.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

US (1)