Fractional Flow Reserve to Determine Atherosclerosis Renal Hypertension Stenting (FAIR-Pilot)

Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renal 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.

Study Overview

• Status: Recruiting
• Conditions: Renal Artery Stenosis Atherosclerotic; Secondary Hypertension Renal Arterial
• Intervention / Treatment: Drug: Dopamine; Diagnostic test: Fractional Flow Reserve, Renal; Device: Renal artery stenting

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuxi Li, MD; Phone Number: 00861083572283; Email: liyuxi@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Principal Investigator: Jianping Li, MD
      • Contact: Yuxi Li, MD; Phone Number: 00861083572283; Email: liyuxi@pku.edu.cn
      • Sub-Investigator: Yuxi Li, MD
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Wuqiang Che, MD
      • Principal Investigator: Jingang Zheng, MD
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Jixuan Liu, MD
      • Principal Investigator: Hui Chen, MD
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Miao Yu, MD
      • Principal Investigator: Dongmei Shi, MD
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Guozhu Chen, MD
      • Principal Investigator: Li Su, MD
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • The Second Affiliated Hospital of Soochow University
      • Principal Investigator: Hui Li, MD
      • Contact: Li Xiang, MD
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Yue Zhou, MD
      • Principal Investigator: Renqiang Yang
  • Shandong
    • Zibo, Shandong, China
      • Recruiting
      • Zibo Central Hospital
      • Contact: Hui Zhou, MD
      • Principal Investigator: Hui Zhou, MD
  • Shanxi
    • Taiyuan, Shanxi, China, 030009
      • Recruiting
      • Peking University First Hospital Taiyuan Hospital
      • Contact: Jingbo Mu, MD
      • Principal Investigator: Dengfeng Ma, MD
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin First Central Hospital
      • Contact: Yue Li, MD
      • Principal Investigator: Chengzhi Lu, MD
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Beichen Hospital
      • Contact: Xuena Bi
      • Principal Investigator: Zhi Jia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	From baseline to 1 year post-procedure
Change in ABPM		From baseline to 6 months, 1 year post-procedure
All-cause death		From baseline to 1 year post-procedure
Cardiac death		From baseline to 1 year post-procedure
Acute myocardial infarction incidence	Based on universal definition of acute myocardial infarction	From baseline to 1 year post-procedure
Non-fatal stroke incidence	Based on medical records under outcome committee's judge	From baseline to 1 year post-procedure
Rehospitalization due to heart failure incidence	Based on medical records under outcome committee's judge	From baseline to 1 year post-procedure
Increase in serum creatinine or dialysis		From baseline to 1 year post-procedure

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Estimated): December 8, 2023
• Study Completion (Estimated): December 8, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Atherosclerosis; Renal Artery Obstruction; Hypertension, Renal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Sympathomimetics; Dopamine
• Other Study ID Numbers: 2022CR77

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No