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

Primary Purpose

Renal Artery Stenosis Atherosclerotic, Secondary Hypertension Renal Arterial

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dopamine
Fractional Flow Reserve, Renal
Renal artery stenting
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Artery Stenosis Atherosclerotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China-Japan Friendship HospitalRecruiting
  • Peking University First HospitalRecruiting
  • Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting
  • The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The Second Affiliated Hospital of Soochow UniversityRecruiting
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting
  • Zibo Central HospitalRecruiting
  • Peking University First Hospital Taiyuan HospitalRecruiting
  • Tianjin Beichen HospitalRecruiting
  • Tianjin First Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Not stenting

Stenting

Arm Description

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.

Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.

Outcomes

Primary Outcome Measures

Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
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)

Secondary Outcome Measures

Change in systolic blood pressure as measured by 24-hour ABPM
Change in diastolic blood pressure as measured by 24-hour ABPM
Change in home blood pressure
Change in office blood pressure
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)
Change in ABPM
All-cause death
Cardiac death
Acute myocardial infarction incidence
Based on universal definition of acute myocardial infarction
Non-fatal stroke incidence
Based on medical records under outcome committee's judge
Rehospitalization due to heart failure incidence
Based on medical records under outcome committee's judge
Increase in serum creatinine or dialysis

Full Information

First Posted
January 27, 2023
Last Updated
September 26, 2023
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05732077
Brief Title
Fractional Flow Reserve to Determine Atherosclerosis Renal Hypertension Stenting
Acronym
FAIR-Pilot
Official Title
Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renal Hypertension Patients: a Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
December 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis Atherosclerotic, Secondary Hypertension Renal Arterial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Not stenting
Arm Type
Other
Arm Description
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.
Arm Title
Stenting
Arm Type
Other
Arm Description
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.
Intervention Type
Drug
Intervention Name(s)
Dopamine
Intervention Description
A bolus dose of 50μg/kg dopamine via renal artery to induce hyperemic status
Intervention Type
Diagnostic Test
Intervention Name(s)
Fractional Flow Reserve, Renal
Intervention Description
Renal FFR will be measured based on SOP
Intervention Type
Device
Intervention Name(s)
Renal artery stenting
Intervention Description
Renal artery stenting will be implanted based on the protocol
Primary Outcome Measure Information:
Title
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
Title
Change in the composite index of antihypertensive drugs
Description
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 Outcome Measure Information:
Title
Change in systolic blood pressure as measured by 24-hour ABPM
Time Frame
From baseline to 3 months post-procedure
Title
Change in diastolic blood pressure as measured by 24-hour ABPM
Time Frame
From baseline to 3 months post-procedure
Title
Change in home blood pressure
Time Frame
From baseline to 3 months post-procedure
Title
Change in office blood pressure
Time Frame
From baseline to 3 months post-procedure
Title
Change in the composite index of antihypertensive drugs to reach target blood pressure
Description
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
Title
Change in ABPM
Time Frame
From baseline to 6 months, 1 year post-procedure
Title
All-cause death
Time Frame
From baseline to 1 year post-procedure
Title
Cardiac death
Time Frame
From baseline to 1 year post-procedure
Title
Acute myocardial infarction incidence
Description
Based on universal definition of acute myocardial infarction
Time Frame
From baseline to 1 year post-procedure
Title
Non-fatal stroke incidence
Description
Based on medical records under outcome committee's judge
Time Frame
From baseline to 1 year post-procedure
Title
Rehospitalization due to heart failure incidence
Description
Based on medical records under outcome committee's judge
Time Frame
From baseline to 1 year post-procedure
Title
Increase in serum creatinine or dialysis
Time Frame
From baseline to 1 year post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxi Li, MD
Phone
00861083572283
Email
liyuxi@pku.edu.cn
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wuqiang Che, MD
First Name & Middle Initial & Last Name & Degree
Jingang Zheng, MD
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxi Li, MD
Phone
00861083572283
Email
liyuxi@pku.edu.cn
First Name & Middle Initial & Last Name & Degree
Jianping Li, MD
First Name & Middle Initial & Last Name & Degree
Yuxi Li, MD
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miao Yu, MD
First Name & Middle Initial & Last Name & Degree
Dongmei Shi, MD
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jixuan Liu, MD
First Name & Middle Initial & Last Name & Degree
Hui Chen, MD
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhu Chen, MD
First Name & Middle Initial & Last Name & Degree
Li Su, MD
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xiang, MD
First Name & Middle Initial & Last Name & Degree
Hui Li, MD
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Zhou, MD
First Name & Middle Initial & Last Name & Degree
Renqiang Yang
Facility Name
Zibo Central Hospital
City
Zibo
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhou, MD
First Name & Middle Initial & Last Name & Degree
Hui Zhou, MD
Facility Name
Peking University First Hospital Taiyuan Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingbo Mu, MD
First Name & Middle Initial & Last Name & Degree
Dengfeng Ma, MD
Facility Name
Tianjin Beichen Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuena Bi
First Name & Middle Initial & Last Name & Degree
Zhi Jia, MD
Facility Name
Tianjin First Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Li, MD
First Name & Middle Initial & Last Name & Degree
Chengzhi Lu, MD

12. IPD Sharing Statement

Learn more about this trial

Fractional Flow Reserve to Determine Atherosclerosis Renal Hypertension Stenting

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