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RecruitingNCT05732077FAIR-PilotUpdated Jun 6, 2024

Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

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 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-06.

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

Phase
Not applicable
Study type
Interventional
Enrollment
100
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. 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.

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 (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

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.
04

Study design

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

Study arms

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

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

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. Increase in serum creatinine or dialysis

    Time frame: From baseline to 1 year post-procedure

06

Study locations

13 of 13 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, Beijing 100029, China
    • Wuqiang Che, MD · Contact
    • Jingang Zheng, MD · Principal investigator
    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
  • Beijing Chao-yang hospital, capital medical university
    Beijing, Beijing 100123, China
    • Chuang Li, MD · Contact
    • Li Xu, MD · Principal investigator
    Recruiting
  • Beijing Anzhen Hospital, Capital Medical University
    Beijing, Beijing, China
    • Miao Yu, MD · Contact
    • Dongmei Shi, MD · Principal investigator
    Recruiting
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing, China
    • Jixuan Liu, MD · Contact
    • Hui Chen, MD · Principal investigator
    Recruiting
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing, China
    • Guozhu Chen, MD · Contact
    • Li Su, MD · Principal investigator
    Recruiting
  • The Second Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
    • Li Xiang, MD · Contact
    • Hui Li, MD · Principal investigator
    Recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    • Yue Zhou, MD · Contact
    • Renqiang Yang · Principal investigator
    Recruiting
  • Qinghai province cardiovascular and cerebrovascular disease specialist hospital
    Xining, Qinghai 810012, China
    • Cun Liu, MD · Contact
    • Cun Liu, MD · Principal investigator
    Recruiting
  • Zibo Central Hospital
    Zibo, Shandong, China
    • Hui Zhou, MD · Contact
    • Hui Zhou, MD · Principal investigator
    Recruiting
  • Peking University First Hospital Taiyuan Hospital
    Taiyuan, Shanxi 030009, China
    • Jingbo Mu, MD · Contact
    • Dengfeng Ma, MD · Principal investigator
    Recruiting
  • Tianjin Beichen Hospital
    Tianjin, Tianjin, China
    • Xuena Bi · Contact
    • Zhi Jia, MD · Principal investigator
    Recruiting
  • Tianjin First Central Hospital
    Tianjin, Tianjin, China
    • Yue Li, MD · Contact
    • Chengzhi Lu, MD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT05732077
Lead sponsor
Peking University First Hospital
Responsible party
Jianping LI (Professor, Peking University First Hospital) — Principal investigator
First posted
Feb 16, 2023
Start date
Jan 31, 2023
Primary completion
Mar 31, 2025 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Jun 6, 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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