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Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

Primary Purpose

Vascular Ehlers-Danlos Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heartmath Intervention
Control Group
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vascular Ehlers-Danlos Syndrome focused on measuring Cardiovascular, Mental Health, Heart Rate Variability

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Percent Reduction in Mean Overall Systolic Blood Pressure
Meaningful 5% reduction in overall systolic blood pressure

Secondary Outcome Measures

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
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
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
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
Diurnal Systolic blood pressure
mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, diurnal reading
Diurnal Diastolic blood pressure
mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, diurnal reading
Daily Systolic blood pressure
mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
Daily Diastolic blood pressure
mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
Coherence Percentage
Between 0.04-0.24 Hz (3-15 cycles per min), The more stable and regular the heart rhythm frequency is the higher the coherence. Percent ranges from 0.5 Basic good beginner level, 1.0 Good, 2.0 Very Good, 3.0+ Excellent. The higher the percentage the better.
Heart rate variability
Consists of beat to beat changes in heart rate measured by values below 50 ms are classified as unhealthy, 50-100 ms have compromised health, and above 100 ms are classified as healthy.
Mean Heart Rate
Measured for 24 hrs, range of 60-100 bpm
Nocturnal Heart Rate
Adolescent: 50-90 bpm and Adult: 40-50 bpm, measured for 24 hours
Diurnal Heart Rate
Adolescent: 60-100 bmp and Adult: 60-100 bmp, measured for 24 hours
Quality of Life Scale (QOLS) (ages 19-21 y)
16 items, each with 7 point Likert, higher is worse
Pediatric Quality of Life Scale (PedsQL) scale scores
reported in 3 domains, each reported on Likert scale, scaled to 0-100 scale, lower is worse
GAD-7
Seven-item questionnaire that detects generalized anxiety disorder and the severity of the anxiety. Total score for the seven items ranges from 0 to 21. The higher the score the worse; cut off score is 8.
PSC
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
PSC-Y
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.PSC Subscales:Attention Problems, Internalizing Problems, Externalizing Problems
PSC-Y Attention Subscale
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales:Attention Problems Subscale: Children with subscores greater than or equal to 7 usually have significant impairments in attention.
PSC-Y Internalizing Problems Subscale
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales: Internalizing Problems Subscale: Children with subscores greater than or equal to 5 usually have significant impairments with anxiety or depression.
PSC-Y Externalizing Problems Subscale
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales: Externalizing Problems Subscale: Children with subscores greater than or equal to 7 usually have significant problems with conduct.
PROMIS Pediatric Self- Reported Psychological Stress
PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. On the T-score metric, A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Better health is a lower score and worse health scores higher.
PROMIS Parent Proxy Reported Psychological Stress- Parent Proxy
PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. On the T-score metric, A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher score is worse health.
The PROMIS Adult Depression SF v1.0 8a
Adult measure is the 8-item PROMIS Depression Short Form v1.0 8a questionnaire that assesses the pure domain of depression in individuals age 18 and older. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average.
The PROMIS Pediatric Depression SF V2.0 8a
The PROMIS Short Form v2.0 - Depression 8a questionnaire includes 8 questions related to depressed mood in the past 7 days for ages 8-17. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average.
The PROMIS Parent Proxy Depression SF v2.0 6a
The PROMIS Short Form v2.0 - Depression 6a questionnaire includes 6 questions related to depressed mood in the past 7 days for parents serving as proxy reporters for their child (youth ages 5-17). A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average.

Full Information

First Posted
August 9, 2023
Last Updated
August 9, 2023
Sponsor
Baylor College of Medicine
Collaborators
Southern Star Research Pty Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05994664
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Southern Star Research Pty Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Ehlers-Danlos Syndrome
Keywords
Cardiovascular, Mental Health, Heart Rate Variability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Trial will have two parallel groups and randomization will be performed at a 1:1 allocation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Heartmath Intervention
Intervention Description
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 Type
Other
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Reduction in Mean Overall Systolic Blood Pressure
Description
Meaningful 5% reduction in overall systolic blood pressure
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Mean systolic blood pressure
Description
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
Title
Mean Diastolic blood pressure
Description
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
Title
Nocturnal systolic blood pressure
Description
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
Title
Nocturnal Diastolic blood pressure
Description
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
Title
Diurnal Systolic blood pressure
Description
mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, diurnal reading
Time Frame
3 Month
Title
Diurnal Diastolic blood pressure
Description
mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, diurnal reading
Time Frame
3 Month
Title
Daily Systolic blood pressure
Description
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
Title
Daily Diastolic blood pressure
Description
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
Title
Coherence Percentage
Description
Between 0.04-0.24 Hz (3-15 cycles per min), The more stable and regular the heart rhythm frequency is the higher the coherence. Percent ranges from 0.5 Basic good beginner level, 1.0 Good, 2.0 Very Good, 3.0+ Excellent. The higher the percentage the better.
Time Frame
3 Months
Title
Heart rate variability
Description
Consists of beat to beat changes in heart rate measured by values below 50 ms are classified as unhealthy, 50-100 ms have compromised health, and above 100 ms are classified as healthy.
Time Frame
3 Months
Title
Mean Heart Rate
Description
Measured for 24 hrs, range of 60-100 bpm
Time Frame
Measured at baseline and follow up visit (at 12 weeks)
Title
Nocturnal Heart Rate
Description
Adolescent: 50-90 bpm and Adult: 40-50 bpm, measured for 24 hours
Time Frame
Measured at baseline and follow up visit (at 12 weeks)
Title
Diurnal Heart Rate
Description
Adolescent: 60-100 bmp and Adult: 60-100 bmp, measured for 24 hours
Time Frame
Measured at baseline and follow up visit (at 12 weeks)
Title
Quality of Life Scale (QOLS) (ages 19-21 y)
Description
16 items, each with 7 point Likert, higher is worse
Time Frame
3 Months
Title
Pediatric Quality of Life Scale (PedsQL) scale scores
Description
reported in 3 domains, each reported on Likert scale, scaled to 0-100 scale, lower is worse
Time Frame
3 Months
Title
GAD-7
Description
Seven-item questionnaire that detects generalized anxiety disorder and the severity of the anxiety. Total score for the seven items ranges from 0 to 21. The higher the score the worse; cut off score is 8.
Time Frame
3 Months
Title
PSC
Description
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
Time Frame
3 Months
Title
PSC-Y
Description
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.PSC Subscales:Attention Problems, Internalizing Problems, Externalizing Problems
Time Frame
3 Months
Title
PSC-Y Attention Subscale
Description
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales:Attention Problems Subscale: Children with subscores greater than or equal to 7 usually have significant impairments in attention.
Time Frame
3 Months
Title
PSC-Y Internalizing Problems Subscale
Description
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales: Internalizing Problems Subscale: Children with subscores greater than or equal to 5 usually have significant impairments with anxiety or depression.
Time Frame
3 Months
Title
PSC-Y Externalizing Problems Subscale
Description
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales: Externalizing Problems Subscale: Children with subscores greater than or equal to 7 usually have significant problems with conduct.
Time Frame
3 Months
Title
PROMIS Pediatric Self- Reported Psychological Stress
Description
PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. On the T-score metric, A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Better health is a lower score and worse health scores higher.
Time Frame
3 Months
Title
PROMIS Parent Proxy Reported Psychological Stress- Parent Proxy
Description
PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. On the T-score metric, A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher score is worse health.
Time Frame
3 Months
Title
The PROMIS Adult Depression SF v1.0 8a
Description
Adult measure is the 8-item PROMIS Depression Short Form v1.0 8a questionnaire that assesses the pure domain of depression in individuals age 18 and older. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average.
Time Frame
3 Months
Title
The PROMIS Pediatric Depression SF V2.0 8a
Description
The PROMIS Short Form v2.0 - Depression 8a questionnaire includes 8 questions related to depressed mood in the past 7 days for ages 8-17. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average.
Time Frame
3 Months
Title
The PROMIS Parent Proxy Depression SF v2.0 6a
Description
The PROMIS Short Form v2.0 - Depression 6a questionnaire includes 6 questions related to depressed mood in the past 7 days for parents serving as proxy reporters for their child (youth ages 5-17). A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaine A Morris, MD, MPH
Phone
832-826-5692
Email
shainem@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Bogardus, PT, MPT, PhD
Phone
713-794-2070
Email
jennifer.bogardus@utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaine A Morris, MD, MPH
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

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