Renal Artery Fibromuscular DysplasiaNCT05363748
Renal Artery Fibromuscular Dysplasia Registry
An observational study of Renal Artery Fibromuscular Dysplasia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
1. Study name: A Prospective Study of the Renal artery fibromuscular dysplasia Registry in China 2. Rationale: Fibromuscular dysplasia (FMD) is an idiopathic systemic noninflammatory arterial disease resulting in narrowing of medium-sized arteries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Artery Fibromuscular Dysplasia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2036
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with renal artery fibromuscular dysplasia who signed the informed consent will be eligible. The following patients are eligible for inclusion: 1) Patients with established renal artery FMD, at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). 2) Patients with so-called "atypical FMD" or "FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms < 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy. 3) Children with renal artery FMD may be also included, provided they meet the inclusion criteria and there is no evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis.
Who may be able to join
- Informed consent;
- Patients diagnosed with renal artery fibromuscular dysplasia (FMD), i.e. at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). The diagnosis needs to be confirmed by at least one of the following imaging modalities: CT-angiography, MR-angiography or catheter-based angiography;
- Patients with so-called "atypical renal artery FMD" or "renal artery FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms < 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy;
- Patients with established renal artery FMD younger than 18 years, without evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis;
Who cannot join
- 1. Not eligible for inclusion or in situations considered unqualified for the study by the investigator;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jiguang Wang, PhD, +86-21-64370045 ext. 610911, jiguangw@163.com
About this study
Official title: A Prospective Study of the Renal Artery Fibromuscular Dysplasia Registry in China
- Study name: A Prospective Study of the Renal artery fibromuscular dysplasia Registry in China
- Rationale: Fibromuscular dysplasia (FMD) is an idiopathic systemic noninflammatory arterial disease resulting in narrowing of medium-sized arteries. Renal arteries are most commonly involved vessels, although it can also affect arteries in other vascular territories. Renal artery FMD is the second frequent cause of renovascular hypertension , especially in adolescents. The pathogenesis of FMD is still not understood. There were little Asians in the United States and the European/International FMD registry.
- Objective: 1) To describe the characteristics of renal artery FMD; 2) To identify environmental/ hormonal factors and exposures (for example smoking) associated with the onset and progression of renal artery FMD; 3)To identify baseline characteristics of the disease associated with an increased risk of complications such as dissections, aneurysms, stroke or myocardial infarction; 4) To provide evidence-based algorithms for the management and follow-up of patients with renal artery FMD; 5) To establish a comprehensive imaging resource including a wide range of presentations of renal artery FMD.
- Study design: Prospective, multi-center, observational study.
- Study population: renal artery fibromuscular dysplasia
- Data Collections: 1) Data on demographic characteristics, clinical characteristics, blood routine, biochemical and plasmic electrolytes and vascular imaging were collected using a questionnaire; 2) The diagnosis of renal artery FMD was based on the identification of focal or multifocal FMD lesions in at least one arterial bed by computed tomography angiography, magnetic resonance angiography and/or digital subtraction angiographies; 3) For the patients with renal artery FMD, screening was performed to assess most arteries and multivessel FMD would be collected; 4) All patients would be followed up.
- Treatment: Standardized diagnosis and treatment procedure as recommended in the International Consensus on the diagnosis and management of fibromuscular dysplasia.
- Follow up: 3, 6, 12 months after diagnosis and every year after enrolled.
- Sample size estimation: About 5 hundred.
- Timeline: Start of subjects' enrollment: Jan 2021; End of subjects enrollment: December 2026; End of study: December 2036.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Read the detailed description
- Study name: A Prospective Study of the Renal artery fibromuscular dysplasia Registry in China
- Rationale: Fibromuscular dysplasia (FMD) is an idiopathic systemic noninflammatory arterial disease resulting in narrowing of medium-sized arteries and causes stenosis, aneurysm, occlusion, or dissection. Renal arteries are most commonly involved vessels, although it can also affect arteries in other vascular territories. Renal artery FMD is the second frequent cause of renovascular hypertension (RVH), especially in adolescents. FMD often affects two or more arterial beds (prevalence of multivessel FMD: 57 to 66%). Despite traditional views on the role of female hormones, mechanical factors and, more recently, smoking, the pathophysiology of FMD is still not well understood. There were little Asians in the United States and the European/International FMD registry.
- Objective: 1) To describe the characteristics of renal artery FMD in men and women, older and younger patients and according to different arterial manifestations, ethnic origin in order to individualize management and prevent complications; 2) To identify environmental/ hormonal factors and exposures (for example smoking) associated with the onset and progression of renal artery FMD;3)To identify baseline characteristics of the disease associated with an increased risk of complications such as dissections, aneurysms, stroke or myocardial infarction; 4) To provide evidence-based algorithms for the optimal management and follow-up of patients with renal artery FMD; 5) To establish a comprehensive imaging resource including a wide range of presentations of renal artery FMD, which may be used to improve knowledge and raise awareness in the medical community.
- Study design: Prospective, multi-center, observational study.
- Study population: patients with renal artery fibromuscular dysplasia who signed the informed consent will be eligible. The following patients are eligible for inclusion: 1) Patients with established renal artery FMD, at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). 2) Patients with so-called "atypical FMD" or "FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms < 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy. 3) Children with renal artery FMD may be also included, provided they meet the inclusion criteria and there is no evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis.
- Data Collections: 1) Data on demographic characteristics (age, gender, height, and ethnicity), clinical characteristics [seated office systolic and diastolic blood pressure (BP), smoking, family history on hypertension or FMD, concomitant diseases, current medications, age at diagnosis of renal artery FMD, angiographic subtype of renal artery FMD, symptoms of renal artery FMD at diagnosis and associated atheroma lesions], blood routine, biochemical and plasmic electrolytes and vascular imaging (arterial beds explored, imaging modality, type, and site of lesions for each vascular bed) were collected using a questionnaire; 2) The diagnosis of renal artery FMD was based on the identification of focal or multifocal FMD lesions in at least one arterial bed by computed tomography angiography (CTA), magnetic resonance angiography(MRA) and/or digital subtraction angiographies (DSA), as recommended in the first international FMD Consensus; 3) For the patients with renal artery FMD, screening was performed to assess all arteries (for example: cerebrovascular, mesenteric, aorta, renal, coronary, visceral, upper and lower extremity arteries) and multivessel FMD would be collected. 4) All patients would be followed up and data ( for example: the blood pressure and restenosis) would be evaluated again.
- Treatment: Standardized diagnosis and treatment procedure as recommended in the International Consensus on the diagnosis and management of fibromuscular dysplasia.
- Follow up: 3, 6, 12 months after diagnosis and every year after enrolled.
- Sample size estimation: About 5 hundred.
- Timeline: Start of subjects' enrollment: Jan 2021; End of subjects enrollment: December 2026; End of study: December 2036.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
- Conditions
- Renal Artery Fibromuscular Dysplasia
- Keywords
- Renal Artery Fibromuscular Dysplasia, Hypertension
- Medical subject headings
- Hypertension
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 |
|---|---|---|
| Observation group | sequential |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of focal or multifocal FMD
The percentage of focal or multifocal subtype in the renal artery FMD in China
Measured: 1 day
The percentage of multivessel FMD in the renal artery FMD
The percentage of multivessel FMD in the renal artery FMD in China
Measured: 1 week
The change of blood pressure
Comparison of blood pressure between baseline and 3/6/12 months (every year) after percutaneous transluminal angioplasty.
Measured: 10 years
The rate of restenosis of renal artery FMD
The rate of restenosis of renal artery FMD after percutaneous transluminal angioplasty
Measured: 10 years
The rate of incidence of cardiovascular events
The rate of incidence of cardiovascular events in the renal artery FMD patients, such as cerebral infarction, hypertensive nephropathy, myocardial infarction and so on.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Oct 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery Fibromuscular DysplasiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiguang Wang, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363748
- Sponsor's protocol ID
- RA-FMD
- Status last verified
- Nov 2023
- First submitted
- 1 Apr 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Renal Artery Fibromuscular Dysplasia Registry in China
- ClinicalTrials.gov ID
- NCT05363748
- Acronym / sponsor ID
- RA-FMD
- Conditions
- Renal Artery Fibromuscular Dysplasia
- Keywords
- Renal Artery Fibromuscular Dysplasia, Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 6 May 2022 (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.
- Study name: A Prospective Study of the Renal artery fibromuscular dysplasia Registry in China
- Rationale: Fibromuscular dysplasia (FMD) is an idiopathic systemic noninflammatory arterial disease resulting in narrowing of medium-sized arteries. Renal arteries are most commonly involved vessels, although it can also affect arteries in other vascular territories. Renal artery FMD is the second frequent cause of renovascular hypertension , especially in adolescents. The pathogenesis of FMD is still not understood. There were little Asians in the United States and the European/International FMD registry.
- Objective: 1) To describe the characteristics of renal artery FMD; 2) To identify environmental/ hormonal factors and exposures (for example smoking) associated with the onset and progression of renal artery FMD; 3)To identify baseline characteristics of the disease associated with an increased risk of complications such as dissections, aneurysms, stroke or myocardial infarction; 4) To provide evidence-based algorithms for the management and follow-up of patients with renal artery FMD; 5) To establish a comprehensive imaging resource including a wide range of presentations of renal artery FMD.
- Study design: Prospective, multi-center, observational study.
- Study population: renal artery fibromuscular dysplasia
- Data Collections: 1) Data on demographic characteristics, clinical characteristics, blood routine, biochemical and plasmic electrolytes and vascular imaging were collected using a questionnaire; 2) The diagnosis of renal artery FMD was based on the identification of focal or multifocal FMD lesions in at least one arterial bed by computed tomography angiography, magnetic resonance angiography and/or digital subtraction angiographies; 3) For the patients with renal artery FMD, screening was performed to assess most arteries and multivessel FMD would be collected; 4) All patients would be followed up.
- Treatment: Standardized diagnosis and treatment procedure as recommended in the International Consensus on the diagnosis and management of fibromuscular dysplasia.
- Follow up: 3, 6, 12 months after diagnosis and every year after enrolled.
- Sample size estimation: About 5 hundred.
- Timeline: Start of subjects' enrollment: Jan 2021; End of subjects enrollment: December 2026; End of study: December 2036.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Detailed description
- Study name: A Prospective Study of the Renal artery fibromuscular dysplasia Registry in China
- Rationale: Fibromuscular dysplasia (FMD) is an idiopathic systemic noninflammatory arterial disease resulting in narrowing of medium-sized arteries and causes stenosis, aneurysm, occlusion, or dissection. Renal arteries are most commonly involved vessels, although it can also affect arteries in other vascular territories. Renal artery FMD is the second frequent cause of renovascular hypertension (RVH), especially in adolescents. FMD often affects two or more arterial beds (prevalence of multivessel FMD: 57 to 66%). Despite traditional views on the role of female hormones, mechanical factors and, more recently, smoking, the pathophysiology of FMD is still not well understood. There were little Asians in the United States and the European/International FMD registry.
- Objective: 1) To describe the characteristics of renal artery FMD in men and women, older and younger patients and according to different arterial manifestations, ethnic origin in order to individualize management and prevent complications; 2) To identify environmental/ hormonal factors and exposures (for example smoking) associated with the onset and progression of renal artery FMD;3)To identify baseline characteristics of the disease associated with an increased risk of complications such as dissections, aneurysms, stroke or myocardial infarction; 4) To provide evidence-based algorithms for the optimal management and follow-up of patients with renal artery FMD; 5) To establish a comprehensive imaging resource including a wide range of presentations of renal artery FMD, which may be used to improve knowledge and raise awareness in the medical community.
- Study design: Prospective, multi-center, observational study.
- Study population: patients with renal artery fibromuscular dysplasia who signed the informed consent will be eligible. The following patients are eligible for inclusion: 1) Patients with established renal artery FMD, at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). 2) Patients with so-called "atypical FMD" or "FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms < 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy. 3) Children with renal artery FMD may be also included, provided they meet the inclusion criteria and there is no evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis.
- Data Collections: 1) Data on demographic characteristics (age, gender, height, and ethnicity), clinical characteristics [seated office systolic and diastolic blood pressure (BP), smoking, family history on hypertension or FMD, concomitant diseases, current medications, age at diagnosis of renal artery FMD, angiographic subtype of renal artery FMD, symptoms of renal artery FMD at diagnosis and associated atheroma lesions], blood routine, biochemical and plasmic electrolytes and vascular imaging (arterial beds explored, imaging modality, type, and site of lesions for each vascular bed) were collected using a questionnaire; 2) The diagnosis of renal artery FMD was based on the identification of focal or multifocal FMD lesions in at least one arterial bed by computed tomography angiography (CTA), magnetic resonance angiography(MRA) and/or digital subtraction angiographies (DSA), as recommended in the first international FMD Consensus; 3) For the patients with renal artery FMD, screening was performed to assess all arteries (for example: cerebrovascular, mesenteric, aorta, renal, coronary, visceral, upper and lower extremity arteries) and multivessel FMD would be collected. 4) All patients would be followed up and data ( for example: the blood pressure and restenosis) would be evaluated again.
- Treatment: Standardized diagnosis and treatment procedure as recommended in the International Consensus on the diagnosis and management of fibromuscular dysplasia.
- Follow up: 3, 6, 12 months after diagnosis and every year after enrolled.
- Sample size estimation: About 5 hundred.
- Timeline: Start of subjects' enrollment: Jan 2021; End of subjects enrollment: December 2026; End of study: December 2036.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | –sequential |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with renal artery fibromuscular dysplasia who signed the informed consent will be eligible. The following patients are eligible for inclusion: 1) Patients with established renal artery FMD, at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). 2) Patients with so-called "atypical FMD" or "FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms < 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy. 3) Children with renal artery FMD may be also included, provided they meet the inclusion criteria and there is no evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis.
Key inclusion criteria (4 listed)
- Informed consent;
- Patients diagnosed with renal artery fibromuscular dysplasia (FMD), i.e. at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). The diagnosis needs to be confirmed by at least one of the following imaging modalities: CT-angiography, MR-angiography or catheter-based angiography;
- Patients with so-called "atypical renal artery FMD" or "renal artery FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms < 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy;
- Patients with established renal artery FMD younger than 18 years, without evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis;
Key exclusion criteria (1 listed)
- 1. Not eligible for inclusion or in situations considered unqualified for the study by the investigator;
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
The percentage of focal or multifocal FMD
Time frame: 1 day
The percentage of focal or multifocal subtype in the renal artery FMD in China
The percentage of multivessel FMD in the renal artery FMD
Time frame: 1 week
The percentage of multivessel FMD in the renal artery FMD in China
The change of blood pressure
Time frame: 10 years
Comparison of blood pressure between baseline and 3/6/12 months (every year) after percutaneous transluminal angioplasty.
The rate of restenosis of renal artery FMD
Time frame: 10 years
The rate of restenosis of renal artery FMD after percutaneous transluminal angioplasty
The rate of incidence of cardiovascular events
Time frame: 10 years
The rate of incidence of cardiovascular events in the renal artery FMD patients, such as cerebral infarction, hypertensive nephropathy, myocardial infarction and so on.
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 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jiguang Wang, PhD principal investigator
Ruijin Hospital
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 Renal Artery Fibromuscular Dysplasia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 4 inclusion and 1 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 18 Nov 2023. 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 China. 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 Jiguang Wang, MD, PhD (+86-21-64370045 ext. 610911, jiguangw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of focal or multifocal FMD (time frame: 1 day). The study lists 5 primary outcomes in all. 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 18 Nov 2023.