NCT05363748

Renal Artery Fibromuscular Dysplasia Registry

Recruiting now Last updated 18 November 2023

What this trial tests

trial in Renal Artery Fibromuscular Dysplasia in 500 participants. Currently enrolling.

Timeline

1 October 2021

Primary endpoint
31 December 2026

31 December 2036

Quick facts

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 October 2021
Primary completion	31 December 2026
Estimated completion	31 December 2036
Sites	1 location across China

Conditions studied

• Renal Artery Fibromuscular Dysplasia — all drugs for Renal Artery Fibromuscular Dysplasia →

Sponsor

Shanghai Jiao Tong University School of Medicine

Who can join

Eligibility, any sex, with Renal Artery Fibromuscular Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.