Renal Artery Fibromuscular Dysplasia Registry

NCT05363748 | Recruiting DMC

• 1 other identifier: RA-FMD
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study name: A Prospective Study of the Renal artery fibromuscular dysplasia Registry in China
2. 2.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.
3. 3.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.
4. 4.Study design: Prospective, multi-center, observational study.
5. 5.Study population: renal artery fibromuscular dysplasia
6. 6.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.
7. 7.Treatment: Standardized diagnosis and treatment procedure as recommended in the International Consensus on the diagnosis and management of fibromuscular dysplasia.
8. 8.Follow up: 3, 6, 12 months after diagnosis and every year after enrolled.
9. 9.Sample size estimation: About 5 hundred.
10. 10.Timeline: Start of subjects' enrollment: Jan 2021; End of subjects enrollment: December 2026; End of study: December 2036.
11. 11.Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Conditions

Renal Artery Fibromuscular Dysplasia

Keywords

Renal Artery Fibromuscular Dysplasia; Hypertension

Outcome Measures

Primary Outcomes (5)

• The percentage of focal or multifocal FMD

  The percentage of focal or multifocal subtype in the renal artery FMD in China

  1 day

• The percentage of multivessel FMD in the renal artery FMD

  The percentage of multivessel FMD in the renal artery FMD in China

  1 week

• The change of blood pressure

  Comparison of blood pressure between baseline and 3/6/12 months (every year) after percutaneous transluminal angioplasty.

  10 years

• The rate of restenosis of renal artery FMD

  The rate of restenosis of renal artery FMD after percutaneous transluminal angioplasty

  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.

  10 years

Study Arms (1)

Observation group

sequential

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patients with renal artery FMD will be asked for at least collection of an EDTA sample for DNA extraction.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jiguang Wang, PhD

  Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiguang Wang, MD, PhD

CONTACT

+86-21-64370045; jiguangw@163.com

Jiguang Wang, MD, PhD

CONTACT

+86-21-64370045; iguang_wang_jgw@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension and the Department of Hypertension

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 6, 2022
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2036
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)