Fibromuscular Dysplasia of ArteriesNCT07529691
Survey on Physical Activity and Qualify of Life in Fibromuscular Dysplasia
An observational study of Fibromuscular Dysplasia of Arteries and Fibromuscular Dysplasia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Fibromuscular dysplasia (FMD) is a disease of the arteries that is not due to plaque build-up or inflammation. While some patients with FMD are health, some may experience heart attacks, strokes, aneurysms or blood vessel dissection/tearing which can be life-threatening. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fibromuscular Dysplasia of Arteries, Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with a diagnosis of fibromuscular dysplasia
Who may be able to join
- Participants with a diagnosis of fibromuscular dysplasia
- Age range = 18-100 years
Who cannot join
- Subjects who have an inability to complete the electronic consent form or electronic survey for any reason
- Subjects who are non-English speaking who cannot read the electronic consent form or electronic survey
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Amanda M Morrison, MD, (615) 322-5000, amanda.morrison@vumc.org
amanda.morrison@vumc.org
About this study
Official title: National Survey of Physical Activity Restrictions and Quality of Life Among Patients With Fibromuscular Dysplasia
Fibromuscular dysplasia (FMD) is a disease of the arteries that is not due to plaque build-up or inflammation. While some patients with FMD are health, some may experience heart attacks, strokes, aneurysms or blood vessel dissection/tearing which can be life-threatening. It predominantly impacts women and younger patients. As a result of this diagnosis, many patients are counseled to restrict or avoid certain physical activities out of concern for provoking or worsening vascular complications. There are no guidelines or consensus recommendations regarding appropriate physical activity for patients with FMD. The lack of consensus may lead to confusion for patients and may negatively impact their quality of life. This study will conduct a large, national survey of patients with FMD to assess the type of physical activity restrictions and impact on quality of life and emotional well-being.
Read the detailed description
Fibromuscular dysplasia (FMD) is a non-atherosclerotic, non-inflammatory disease of medium-sized arteries characterized by intimal and medial hyperplasia. The exact prevalence of FMD is unknown, but it predominantly impacts women and middle-age patients, with a mean age of 52 at the time of diagnosis. The manifestations of FMD are variable and may include spontaneous coronary artery dissection (SCAD) as well as extra-coronary vascular abnormalities (EVAs), such as peripheral artery aneurysms or dissections. Many patients are counseled to restrict or avoid certain physical activities out of concern for provoking or worsening vascular complications.3,4 However, there are no guidelines or consensus recommendations regarding appropriate physical activity for patients with FMD in the available 2018 American Heart Association (AHA) Scientific statement or the 2019 first international consensus document on FMD. Recommendations are formed based on expert opinion, and may vary based on a variety of factors including severity of disease, treating institution, or sex. The lack of consensus may lead to confusion for patients and may negatively impact their quality of life. This survey will be delivered electronically via RedCap to participants who self-identify as having a diagnosis of fibromuscular dysplasia. It will be the first to identify the breadth and content, as well as the impact, of physical activity recommendations provided by healthcare personnel to patients with FMD. Data gathered from this study will encourage the creation of an expert consensus document on recommendations for physical activity by FMD phenotype, which will have implications for patient education and empowerment for those living with FMD. This may also lead to areas of future intervention to mitigate adverse quality of life if identified.
- Conditions
- Fibromuscular Dysplasia of Arteries, Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
- Keywords
- FMD, Fibromuscular dysplasia, SCAD, Exercise, Quality of life
- Medical subject headings
- Fibromuscular Dysplasia, Coronary Artery Dissection, Spontaneous, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with fibromuscular dysplasia | Patients who identify as having a confirmed diagnosis of fibromuscular dysplasia, or patients at Vanderbilt University Medical Center who have a confirmed diagnosis of fibromuscular dysplasia as determined by their provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Recommended Physical Activity Restrictions
Prevalence and type of clinician-recommended physical activity restrictions among patients diagnosed with fibromuscular dysplasia (FMD), including aerobic, resistance, and activity-specific limitations.
Measured: Baseline
Secondary outcomes (3)
Self-Reported Change in Physical Activity Following Diagnosis
Change in physical activity behavior following FMD diagnosis based on patient self-report.
Measured: Baseline
Emotional Impact of Physical Activity Recommendations
Self-reported anxiety or depression to physical activity recommendations and/or disease-related limitations.
Measured: Baseline
Physical Impact of Activity Recommendations
Self-reported physical consequences (e.g. weight gain, sedentary lifestyle) associated with modification of activity level following FMD diagnosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start14 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromuscular Dysplasia of ArteriesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fibromuscular Dysplasia Society of America
- Responsible party
- Principal investigator, Amanda Morrison, Vanderbilt University Medical Center
- Investigators
- Aaron W Aday, MD, MSc, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529691
- Sponsor's protocol ID
- 251831
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey of Physical Activity Restrictions and Quality of Life Among Patients With Fibromuscular Dysplasia
- ClinicalTrials.gov ID
- NCT07529691
- Acronym / sponsor ID
- 251831
- Conditions
- Fibromuscular Dysplasia of Arteries, Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
- Keywords
- FMD, Fibromuscular dysplasia, SCAD, Exercise, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Fibromuscular Dysplasia Society of America
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibromuscular dysplasia (FMD) is a disease of the arteries that is not due to plaque build-up or inflammation. While some patients with FMD are health, some may experience heart attacks, strokes, aneurysms or blood vessel dissection/tearing which can be life-threatening. It predominantly impacts women and younger patients. As a result of this diagnosis, many patients are counseled to restrict or avoid certain physical activities out of concern for provoking or worsening vascular complications. There are no guidelines or consensus recommendations regarding appropriate physical activity for patients with FMD. The lack of consensus may lead to confusion for patients and may negatively impact their quality of life. This study will conduct a large, national survey of patients with FMD to assess the type of physical activity restrictions and impact on quality of life and emotional well-being.
Detailed description
Fibromuscular dysplasia (FMD) is a non-atherosclerotic, non-inflammatory disease of medium-sized arteries characterized by intimal and medial hyperplasia. The exact prevalence of FMD is unknown, but it predominantly impacts women and middle-age patients, with a mean age of 52 at the time of diagnosis. The manifestations of FMD are variable and may include spontaneous coronary artery dissection (SCAD) as well as extra-coronary vascular abnormalities (EVAs), such as peripheral artery aneurysms or dissections. Many patients are counseled to restrict or avoid certain physical activities out of concern for provoking or worsening vascular complications.3,4 However, there are no guidelines or consensus recommendations regarding appropriate physical activity for patients with FMD in the available 2018 American Heart Association (AHA) Scientific statement or the 2019 first international consensus document on FMD. Recommendations are formed based on expert opinion, and may vary based on a variety of factors including severity of disease, treating institution, or sex. The lack of consensus may lead to confusion for patients and may negatively impact their quality of life. This survey will be delivered electronically via RedCap to participants who self-identify as having a diagnosis of fibromuscular dysplasia. It will be the first to identify the breadth and content, as well as the impact, of physical activity recommendations provided by healthcare personnel to patients with FMD. Data gathered from this study will encourage the creation of an expert consensus document on recommendations for physical activity by FMD phenotype, which will have implications for patient education and empowerment for those living with FMD. This may also lead to areas of future intervention to mitigate adverse quality of life if identified.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with fibromuscular dysplasia | – | –Patients who identify as having a confirmed diagnosis of fibromuscular dysplasia, or patients at Vanderbilt University Medical Center who have a confirmed diagnosis of fibromuscular dysplasia as determined by their provider. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with a diagnosis of fibromuscular dysplasia
Key inclusion criteria (2 listed)
- Participants with a diagnosis of fibromuscular dysplasia
- Age range = 18-100 years
Key exclusion criteria (2 listed)
- Subjects who have an inability to complete the electronic consent form or electronic survey for any reason
- Subjects who are non-English speaking who cannot read the electronic consent form or electronic survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinician-Recommended Physical Activity Restrictions
Time frame: Baseline
Prevalence and type of clinician-recommended physical activity restrictions among patients diagnosed with fibromuscular dysplasia (FMD), including aerobic, resistance, and activity-specific limitations.
3 secondary outcomes
Self-Reported Change in Physical Activity Following Diagnosis
Time frame: Baseline
Emotional Impact of Physical Activity Recommendations
Time frame: Baseline
Physical Impact of Activity Recommendations
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron W Aday, MD, MSc study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromuscular Dysplasia of Arteries and Fibromuscular Dysplasia, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Morrison, MD (615-322-5000, amanda.morrison@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Recommended Physical Activity Restrictions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.