Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Artery Stenosis Atherosclerotic Secondary Hypertension Renal Arterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Not stenting

Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. If FFR is ≥0.80, randomization will be applied, and no stenting will be implanted. If FFR is \<0.80, randomization will be ignored, and stenting will be performed.

Group Type OTHER

Dopamine

Intervention Type DRUG

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

Fractional Flow Reserve, Renal

Intervention Type DIAGNOSTIC_TEST

Renal FFR will be measured based on SOP

Renal artery stenting

Intervention Type DEVICE

Renal artery stenting will be implanted based on the protocol

Stenting

Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.

Group Type OTHER

Dopamine

Intervention Type DRUG

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

Fractional Flow Reserve, Renal

Intervention Type DIAGNOSTIC_TEST

Renal FFR will be measured based on SOP

Renal artery stenting

Intervention Type DEVICE

Renal artery stenting will be implanted based on the protocol

Interventions

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Dopamine

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

Intervention Type DRUG

Fractional Flow Reserve, Renal

Renal FFR will be measured based on SOP

Intervention Type DIAGNOSTIC_TEST

Renal artery stenting

Renal artery stenting will be implanted based on the protocol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* With recorded hypertension, AND the blood pressure is not controlled (SBP ≥140mmHg and/or DBP ≥90mmHg) on 2 or more classes of anti-hypertensive drugs;
* Evidence of renal artery stenosis and undergoing renal artery angiography;
* Able to follow the study protocol and provide informed consent;
* Renal artery angiography shows at least 1 main artery with stenosis of 50%-90%, AND the diameter is ≥ 4.0mm.

Exclusion Criteria

* SBP ≥200mmHg and/or DBP ≥120mmHg at the day or randomization;
* Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis;
* Pregnancy or unknow pregnancy status in female of childbearing potential;
* Participation in any drug or device trial during the study period;
* Any stroke/TIA, OR with ≥70% stenosis of carotid artery;
* Any major surgery, myocardial infarction or interventional therapy 30 days prior to study entry;
* LVEF \<30%;
* Comorbid condition causing life expectancy ≤1 year;
* Allergy to contrast or any of the following: aspirin, clopidogrel;
* Previous kidney transplant;
* Previous renal artery bypass surgery or stent intervention;
* Kidney size less than 8 cm measured by ultrasound;
* Local lab serum Cr \>3.0 mg/dl (265.2μmol/l) on the day of randomization;
* Reference vessel size \<4 mm or \>8 mm.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jianping LI

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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