RecruitingNot ApplicableNCT05732077

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


Sponsor

Peking University First Hospital

Enrollment

100 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a technique called fractional flow reserve (FFR) — a pressure measurement taken during a procedure to look at the arteries in your kidneys — to decide whether inserting a stent to open a narrowed kidney artery will help control high blood pressure. Some people have high blood pressure because of a blockage in the arteries supplying their kidneys. This study compares stenting guided by FFR measurements versus standard care. **You may be eligible if...** - You have high blood pressure that is not well controlled despite taking 2 or more blood pressure medications - Your kidney artery is 50–90% narrowed due to hardening of the arteries (atherosclerosis), confirmed by imaging - The narrowed artery is at least 4mm wide - You are having a kidney artery procedure as part of your care **You may NOT be eligible if...** - Your blood pressure is dangerously high (above 200/120 mmHg) on the day of the procedure - The narrowing is caused by a non-atherosclerosis condition (like fibromuscular dysplasia) - You are pregnant or may be pregnant - You have had a stroke, TIA, or major surgery in the past 30 days - Your heart pumping function is very poor (ejection fraction below 30%) - You have had a previous kidney transplant or kidney artery surgery/stenting - Your kidney is very small (less than 8 cm) or kidney function is severely impaired - You are allergic to aspirin, clopidogrel, or contrast dye Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDopamine

A bolus dose of 50μg/kg dopamine via renal artery to induce hyperemic status

DIAGNOSTIC_TESTFractional Flow Reserve, Renal

Renal FFR will be measured based on SOP

DEVICERenal 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05732077


Related Trials