Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis (FAIR)

Fractional Flow Reserve-guided Percutaneous Renal Artery Stenting Plus Optimal Medical Therapy Versus Optimal Medical Therapy Alone In Atherosclerosis Renal-vascular Hypertension Patients: a Multicenter 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. Based on the primary finding of FAIR-pilot study (NCT05732077), FFR-guided renal artery stenting is practical.

The overall purpose of the FAIR trial is to compare the clinical outcomes and safety of FFR-guided stenting plus optimal medical treatment (OMT) versus OMT alone in patients with renal-vascular hypertensive patients.

With the 'all comers' design, participants met the inclusive/exclusive criteria will be enrolled, and hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, patients will be treated with OMT alone and follow up. If FFR is <0.80, participants will be randomized to stenting in the renal artery plus OMT or OMT alone on a 1:1 ratio. 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): 200
• 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• With recorded hypertension, AND the blood pressure is not controlled (daytime mean SBP ≥135 mmHg and/or DBP ≥85 mmHg based on ABPM) 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 unknown 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%;
• Comorbidity 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stenting plus OMT with FFR <0.80	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
Placebo Comparator: OMT alone with FFR < 0.80	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
Other: OMT alone with FFR ≥0.80	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

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
Change 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): June 3, 2024
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): April 3, 2027

Study Registration Dates

• First Submitted: June 2, 2024
• First Submitted That Met QC Criteria: June 2, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Constriction, Pathologic; 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: 2024研210-002

Drug and device information, study documents

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