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Renal Artery Stenosis AtheroscleroticFAIR-PilotNCT05732077

Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

A study testing Dopamine, Fractional Flow Reserve, Renal and Renal artery stenting in people with Renal Artery Stenosis Atherosclerotic and Secondary Hypertension Renal Arterial, run by Peking University First Hospital at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dopamine, Fractional Flow Reserve, Renal and Renal artery stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
13 sitesChina
Study dates
31 Jan 2023to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country.

Yuxi Li, MD contact

00861083572283

liyuxi@pku.edu.cn

13 sites in 1 country

China13 sites, 13 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    Wuqiang Che, MD

    Jingang Zheng, MD

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Yuxi Li, MD, 00861083572283, liyuxi@pku.edu.cn

    Jianping Li, MD

    Recruiting

  • Beijing Chao-yang hospital, capital medical university

    Beijing, Beijing Municipality, 100123

    Chuang Li, MD

    Li Xu, MD

    Recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Miao Yu, MD

    Dongmei Shi, MD

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Jixuan Liu, MD

    Hui Chen, MD

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Guozhu Chen, MD

    Li Su, MD

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Yue Zhou, MD

    Renqiang Yang

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Li Xiang, MD

    Hui Li, MD

    Recruiting

  • Peking University First Hospital Taiyuan Hospital

    Taiyuan, Shanxi, 030009

    Jingbo Mu, MD

    Dengfeng Ma, MD

    Recruiting

  • Tianjin Beichen Hospital

    Tianjin, Tianjin Municipality

    Xuena Bi

    Zhi Jia, MD

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality

    Yue Li, MD

    Chengzhi Lu, MD

    Recruiting

  • Qinghai province cardiovascular and cerebrovascular disease specialist hospital

    Xining, Qinghai, 810012

    Cun Liu, MD

    Cun Liu, MD

    Recruiting

  • Zibo Central Hospital

    Zibo, Shandong

    Hui Zhou, MD

    Hui Zhou, MD

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Dopamine, Fractional Flow Reserve, Renal, Renal artery stenting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DopamineDrug

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

  • Fractional Flow Reserve, RenalDiagnostic test

    Renal FFR will be measured based on SOP

  • Renal artery stentingDevice

    Renal artery stenting will be implanted based on the protocol

Study groups in NCT05732077
Study groupRoleWhat they receive
Not stentingOtherHyperemic 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.
Receives: Drug: Dopamine; Diagnostic Test: Fractional Flow Reserve, Renal; Device: Renal artery stenting
StentingOtherHyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.
Receives: Drug: Dopamine; Diagnostic Test: Fractional Flow Reserve, Renal; Device: Renal artery stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

    Measured: From baseline to 3 months post-procedure

  2. Change in the composite index of antihypertensive drugs

    Change in the composite index of antihypertensive drugs. Drug Composite Index = Weight (number of classes of antihypertensive drugs) × (sum of doses)

    Measured: From baseline to 3 months post-procedure

Secondary outcomes (12)

  1. Change in systolic blood pressure as measured by 24-hour ABPM

    Measured: From baseline to 3 months post-procedure

  2. Change in diastolic blood pressure as measured by 24-hour ABPM

    Measured: From baseline to 3 months post-procedure

  3. Change in home blood pressure

    Measured: From baseline to 3 months post-procedure

  4. Change in office blood pressure

    Measured: From baseline to 3 months post-procedure

  5. Change in the composite index of antihypertensive drugs to reach target blood pressure

    Change in the composite index of antihypertensive drugs to reach target blood pressure. Drug Composite Index = Weight (number of classes of antihypertensive drugs) × (sum of doses)

    Measured: From baseline to 1 year post-procedure

  6. Change in ABPM

    Measured: From baseline to 6 months, 1 year post-procedure

  7. All-cause death

    Measured: From baseline to 1 year post-procedure

  8. Cardiac death

    Measured: From baseline to 1 year post-procedure

  9. Acute myocardial infarction incidence

    Based on universal definition of acute myocardial infarction

    Measured: From baseline to 1 year post-procedure

  10. Non-fatal stroke incidence

    Based on medical records under outcome committee's judge

    Measured: From baseline to 1 year post-procedure

  11. Rehospitalization due to heart failure incidence

    Based on medical records under outcome committee's judge

    Measured: From baseline to 1 year post-procedure

  12. Increase in serum creatinine or dialysis

    Measured: From baseline to 1 year post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start31 Jan 2023
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05732077
Sponsor's protocol ID
2022CR77
Acronym
FAIR-Pilot
Status last verified
Jun 2024
First submitted
27 Jan 2023
Last updated
6 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li Y, Zheng J, Lu C, Fan F, Liu Z, Liu S, Yi T, Zhang L, Weng H, Wang B, Liu X, Zhou H, Ma D, Jia Z, Xiang L, Yang R, Shi D, Chen H, Xu L, Liu C, Kario K, Zhang Y, Li J. Fractional flow reserve-guided renal artery stenting in atherosclerotic renovascular hypertension: the FAIR randomized trial. Eur Heart J. 2026 Feb 11;47(6):761-769. doi: 10.1093/eurheartj/ehaf746.

    PubMed 41056188

Questions about this trial

What is this clinical trial studying?

A study testing Dopamine, Fractional Flow Reserve, Renal and Renal artery stenting in people with Renal Artery Stenosis Atherosclerotic and Secondary Hypertension Renal Arterial, run by Peking University First Hospital at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuxi Li, MD (00861083572283, liyuxi@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (time frame: From baseline to 3 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05732077, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.

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