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RECRUITING
NCT05732077
NA

Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-01-31

Completion Date

2025-03-31

Last Updated

2024-06-06

Healthy Volunteers

No

Interventions

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

Locations (13)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Chao-yang hospital, capital medical university

Beijing, Beijing Municipality, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Qinghai province cardiovascular and cerebrovascular disease specialist hospital

Xining, Qinghai, China

Zibo Central Hospital

Zibo, Shandong, China

Peking University First Hospital Taiyuan Hospital

Taiyuan, Shanxi, China

Tianjin Beichen Hospital

Tianjin, Tianjin Municipality, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China