Renal Artery Stenosis AtheroscleroticFAIRNCT06447740
Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis
A study testing Dopamine, Fractional Flow Reserve, Renal and Renal artery stenting in people with Renal Artery Stenosis Atherosclerotic and Secondary Hypertension Renal Arterial, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Stenosis Atherosclerotic, Secondary Hypertension Renal Arterial
- What is being tested?
- Dopamine, Fractional Flow Reserve, Renal and Renal artery stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2024to 3 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yuxi Li, MD, 00861083572283, liyuxi@pku.edu.cn
Jianping Li, MD
About this study
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
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.
- Being tested
- Dopamine, Fractional Flow Reserve, Renal, Renal artery stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopamineDrug
A bolus dose of 50μg/kg dopamine via renal artery to induce hyperemic status
Fractional Flow Reserve, RenalDiagnostic test
Renal FFR will be measured based on SOP
Renal artery stentingDevice
Renal artery stenting will be implanted based on the protocol
| Study group | Role | What they receive |
|---|---|---|
| Stenting plus OMT with FFR <0.80 | Experimental | Not described Receives: Drug: Dopamine; Diagnostic Test: Fractional Flow Reserve, Renal; Device: Renal artery stenting |
| OMT alone with FFR < 0.80 | Placebo comparator | Not described Receives: Drug: Dopamine; Diagnostic Test: Fractional Flow Reserve, Renal |
| OMT alone with FFR ≥0.80 | Other | Not described Receives: Drug: Dopamine; Diagnostic Test: Fractional Flow Reserve, Renal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Measured: 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)
Measured: From baseline to 3 months post-procedure
Secondary outcomes (12)
Change in systolic blood pressure as measured by 24-hour ABPM
Measured: From baseline to 3 months post-procedure
Change in diastolic blood pressure as measured by 24-hour ABPM
Measured: From baseline to 3 months post-procedure
Change in home blood pressure
Measured: From baseline to 3 months post-procedure
Change in office blood pressure
Measured: 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)
Measured: From baseline to 1 year post-procedure
Change in ABPM
Measured: From baseline to 6 months, 1 year post-procedure
All-cause death
Measured: From baseline to 1 year post-procedure
Cardiac death
Measured: From baseline to 1 year post-procedure
Acute myocardial infarction incidence
Based on universal definition of acute myocardial infarction
Measured: From baseline to 1 year post-procedure
Non-fatal stroke incidence
Based on medical records under outcome committee's judge
Measured: From baseline to 1 year post-procedure
Rehospitalization due to heart failure incidence
Based on medical records under outcome committee's judge
Measured: From baseline to 1 year post-procedure
Change in serum creatinine or dialysis
Measured: From baseline to 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start3 Jun 2024
- Primary completion3 Jun 2026 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery Stenosis AtheroscleroticStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447740
- Sponsor's protocol ID
- 2024研210-002
- Acronym
- FAIR
- Status last verified
- Aug 2024
- First submitted
- 2 Jun 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06447740
- Acronym / sponsor ID
- FAIR / 2024研210-002
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 3 Jun 2026 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stenting plus OMT with FFR <0.80 | Experimental | Drug: Dopamine, Diagnostic Test: Fractional Flow Reserve, Renal, Device: Renal artery stenting |
| OMT alone with FFR < 0.80 | Placebo comparator | Drug: Dopamine, Diagnostic Test: Fractional Flow Reserve, Renal |
| OMT alone with FFR ≥0.80 | Other | Drug: Dopamine, Diagnostic Test: Fractional Flow Reserve, Renal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DopamineA bolus dose of 50μg/kg dopamine via renal artery to induce hyperemic status | Drug | OMT alone with FFR < 0.80, OMT alone with FFR ≥0.80, Stenting plus OMT with FFR <0.80 |
| Fractional Flow Reserve, RenalRenal FFR will be measured based on SOP | Diagnostic test | OMT alone with FFR < 0.80, OMT alone with FFR ≥0.80, Stenting plus OMT with FFR <0.80 |
| Renal artery stentingRenal artery stenting will be implanted based on the protocol | Device | Stenting plus OMT with FFR <0.80 |
Primary outcome
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
Change in the composite index of antihypertensive drugs. Drug Composite Index = Weight (number of classes of antihypertensive drugs) × (sum of doses)
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dopamine, Fractional Flow Reserve, Renal and Renal artery stenting in people with Renal Artery Stenosis Atherosclerotic and Secondary Hypertension Renal Arterial, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuxi Li, MD (00861083572283, liyuxi@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.