Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

NCT05732077 | Recruiting

• 1 other identifier: 2022CR77
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 13

Brief 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

Outcome Measures

Primary Outcomes (2)

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

  From baseline to 3 months post-procedure

• 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)

  From baseline to 3 months post-procedure

Secondary Outcomes (12)

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

  From baseline to 3 months post-procedure

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

  From baseline to 3 months post-procedure

• Change in home blood pressure

  From baseline to 3 months post-procedure

• Change in office blood pressure

  From baseline to 3 months post-procedure

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

  From baseline to 1 year post-procedure

Study Arms (2)

Not stenting

OTHER

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.

Drug: Dopamine; Diagnostic Test: Fractional Flow Reserve, Renal; Device: Renal artery stenting

Stenting

OTHER

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

Drug: Dopamine; Diagnostic Test: Fractional Flow Reserve, Renal; Device: Renal artery stenting

Interventions

Dopamine DRUG

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

Not stenting; Stenting

Fractional Flow Reserve, Renal DIAGNOSTIC_TEST

Renal FFR will be measured based on SOP

Not stenting; Stenting

Renal artery stenting DEVICE

Renal artery stenting will be implanted based on the protocol

Not stenting; Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (13)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Beijing Chao-yang hospital, capital medical university

Beijing, Beijing Municipality, 100123, China

RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Qinghai province cardiovascular and cerebrovascular disease specialist hospital

Xining, Qinghai, 810012, China

RECRUITING

Zibo Central Hospital

Zibo, Shandong, China

RECRUITING

Peking University First Hospital Taiyuan Hospital

Taiyuan, Shanxi, 030009, China

RECRUITING

Tianjin Beichen Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (1)

• 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. 2025 Oct 7:ehaf746. doi: 10.1093/eurheartj/ehaf746. Online ahead of print.

  PMID: 41056188 DERIVED

MeSH Terms

Interventions

Dopamine

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Yuxi Li, MD

CONTACT

00861083572283; liyuxi@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 16, 2023
• Study Start: January 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

CN (13)