NCT05732077

Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renovascular Hypertension Patients: a Pilot Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. One important gap is that there is no universal standard to determine whether to stent in these patients. Fraction Flow Reserve (FFR) has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. The goal of this clinical trial is to learn whether Fraction Flow Reserve (FFR) is appropriate to determine stenting in hypertension patients with atherosclerosis renal artery stenosis. The main questions it aims to answer are: * Is it appropriate to use FFR to determine whether or not stenting for hypertension patients with atherosclerosis renal artery stenosis? * To provide detailed data supporting design of further trial, such as sample size calculating, cut-off value for FFR in renal artery stenosis, etc. Participants met the inclusive/exclusive criteria will be randomized to stenting or not in the renal artery, then hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, randomization will be applied. If FFR is \<0.80, randomization will be ignored, and stenting will be performed as planned. The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.

Conditions

• Renal Artery Stenosis Atherosclerotic
• Secondary Hypertension Renal Arterial

Interventions

Type	Name	Description
DRUG	Dopamine	A bolus dose of 50μg/kg dopamine via renal artery to induce hyperemic status
DIAGNOSTIC_TEST	Fractional Flow Reserve, Renal	Renal FFR will be measured based on SOP
DEVICE	Renal artery stenting	Renal artery stenting will be implanted based on the protocol

Timeline

• Start date: 2023-01-31
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2023-02-16
• Last updated: 2024-06-06

Locations

13 sites across 1 country: China