NCT07529691

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

April 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 6, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

FMDFibromuscular dysplasiaSCADExerciseQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (3)

  • Self-Reported Change in Physical Activity Following Diagnosis

    Baseline

  • Emotional Impact of Physical Activity Recommendations

    Baseline

  • Physical Impact of Activity Recommendations

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with a diagnosis of fibromuscular dysplasia

You may qualify if:

  • Participants with a diagnosis of fibromuscular dysplasia
  • Age range = 18-100 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Fibromuscular DysplasiaCoronary Artery Dissection, SpontaneousMotor Activity

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Aaron W Aday, MD, MSc

    Vanderbilt University Medical Center

    STUDY CHAIR

Central Study Contacts

Amanda Morrison, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Medicine Fellow

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 14, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations