Registry for Renal Artery Fibromuscular Dysplasia

A Prospective Study of the Renal Artery Fibromuscular Dysplasia Registry in China

This study is creating a registry to learn more about renal artery fibromuscular dysplasia in patients in China, including what causes it and how to manage it better.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05363748 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a registry for patients diagnosed with renal artery fibromuscular dysplasia (FMD) in China. It seeks to describe the characteristics of FMD, identify environmental and hormonal factors associated with its onset and progression, and assess baseline characteristics that may increase the risk of complications such as dissections or strokes. The study will utilize imaging modalities like CT-angiography and MR-angiography to confirm diagnoses and gather data for analysis. The ultimate goal is to develop evidence-based management algorithms for patients with this condition.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with renal artery FMD, including those with atypical presentations, and individuals younger than 18 years with established FMD.

Not a fit: Patients who do not have a confirmed diagnosis of renal artery FMD or those with underlying syndromes like Williams syndrome or Neurofibromatosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved understanding and management of renal artery FMD, potentially reducing complications for patients.

How similar studies have performed: While there have been registries for FMD in other populations, this specific approach focusing on the Asian demographic is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Informed consent;
2. 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;
3. 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;
4. 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;

Exclusion Criteria:

1\. Not eligible for inclusion or in situations considered unqualified for the study by the investigator;

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jiguang Wang, PhD — Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
• Study coordinator: Jiguang Wang, MD, PhD

Conditions Renal Artery Fibromuscular Dysplasia; Hypertension