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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• 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]
• Change in the composite index of antihypertensive drugs [Time frame: From baseline to 3 months post-procedure]

Secondary outcome measures (12)

• Change in systolic blood pressure as measured by 24-hour ABPM [Time frame: From baseline to 3 months post-procedure]
• Change in diastolic blood pressure as measured by 24-hour ABPM [Time frame: From baseline to 3 months post-procedure]
• Change in home blood pressure [Time frame: From baseline to 3 months post-procedure]
• Change in office blood pressure [Time frame: From baseline to 3 months post-procedure]
• Change in the composite index of antihypertensive drugs to reach target blood pressure [Time frame: From baseline to 1 year post-procedure]
• Change in ABPM [Time frame: From baseline to 6 months, 1 year post-procedure]
• All-cause death [Time frame: From baseline to 1 year post-procedure]
• Cardiac death [Time frame: From baseline to 1 year post-procedure]
• Acute myocardial infarction incidence [Time frame: From baseline to 1 year post-procedure]
• Non-fatal stroke incidence [Time frame: From baseline to 1 year post-procedure]
• Rehospitalization due to heart failure incidence [Time frame: From baseline to 1 year post-procedure]
• Change in serum creatinine or dialysis [Time frame: From baseline to 1 year post-procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University First Hospital — Beijing

Identifiers

NCT: NCT06447740 · 2024研210-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗