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RecruitingNCT06447740FAIRUpdated Aug 16, 2024

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

An interventional study of Dopamine and Fractional Flow Reserve, Renal in Renal Artery Stenosis Atherosclerotic and Secondary Hypertension Renal Arterial, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-16.

Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Renal Artery Stenosis Atherosclerotic
  • Secondary Hypertension Renal Arterial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Stenting plus OMT with FFR <0.80

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

  • Placebo comparator
    OMT alone with FFR < 0.80

    Drug: Dopamine · Diagnostic Test: Fractional Flow Reserve, Renal

  • Other
    OMT alone with FFR ≥0.80

    Drug: Dopamine · Diagnostic Test: Fractional Flow Reserve, Renal

Interventions

  • DrugDopamine

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

  • Diagnostic testFractional Flow Reserve, Renal

    Renal FFR will be measured based on SOP

  • DeviceRenal artery stenting

    Renal artery stenting will be implanted based on the protocol

05

What researchers measure

Primary outcomes

  1. 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

  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)

    Time frame: From baseline to 3 months post-procedure

Secondary outcomes

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

    Time frame: From baseline to 3 months post-procedure

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

    Time frame: From baseline to 3 months post-procedure

  3. Change in home blood pressure

    Time frame: From baseline to 3 months post-procedure

  4. Change in office blood pressure

    Time frame: 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)

    Time frame: From baseline to 1 year post-procedure

  6. Change in ABPM

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

  7. All-cause death

    Time frame: From baseline to 1 year post-procedure

  8. Cardiac death

    Time frame: From baseline to 1 year post-procedure

  9. Acute myocardial infarction incidence

    Based on universal definition of acute myocardial infarction

    Time frame: From baseline to 1 year post-procedure

  10. Non-fatal stroke incidence

    Based on medical records under outcome committee's judge

    Time frame: From baseline to 1 year post-procedure

  11. Rehospitalization due to heart failure incidence

    Based on medical records under outcome committee's judge

    Time frame: From baseline to 1 year post-procedure

  12. Change in serum creatinine or dialysis

    Time frame: From baseline to 1 year post-procedure

06

Study locations

1 of 1 sites recruiting
  • Peking University First Hospital
    Beijing, Beijing 100034, China
    • Yuxi Li, MD · Contact · liyuxi@pku.edu.cn · 00861083572283
    • Jianping Li, MD · Principal investigator
    • Yuxi Li, MD · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06447740
Lead sponsor
Peking University First Hospital
Responsible party
Sponsor
First posted
Jun 7, 2024
Start date
Jun 3, 2024
Primary completion
Jun 3, 2026 (estimated)
Completion
Apr 3, 2027 (estimated)
Last update
Aug 16, 2024

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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