Clinical trial NCT05732077: Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting
Official title: Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renovascular Hypertension Patients: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Artery Stenosis Atherosclerotic
Secondary Hypertension Renal Arterial
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From baseline to 3 months post-procedure
measure: Change in the composite index of antihypertensive drugs
timeFrame: From baseline to 3 months post-procedure
Secondary outcomes:
measure: Change in systolic blood pressure as measured by 24-hour ABPM
timeFrame: From baseline to 3 months post-procedure
measure: Change in diastolic blood pressure as measured by 24-hour ABPM
timeFrame: From baseline to 3 months post-procedure
measure: Change in home blood pressure
timeFrame: From baseline to 3 months post-procedure
measure: Change in office blood pressure
timeFrame: From baseline to 3 months post-procedure
measure: Change in the composite index of antihypertensive drugs to reach target blood pressure
timeFrame: From baseline to 1 year post-procedure
measure: Change in ABPM
timeFrame: From baseline to 6 months, 1 year post-procedure
measure: All-cause death
timeFrame: From baseline to 1 year post-procedure
measure: Cardiac death
timeFrame: From baseline to 1 year post-procedure
measure: Acute myocardial infarction incidence
timeFrame: From baseline to 1 year post-procedure
measure: Non-fatal stroke incidence
timeFrame: From baseline to 1 year post-procedure
measure: Rehospitalization due to heart failure incidence
timeFrame: From baseline to 1 year post-procedure
measure: Increase in serum creatinine or dialysis
timeFrame: From baseline to 1 year post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-yang hospital, capital medical university
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Xining
country: China
facility: Qinghai province cardiovascular and cerebrovascular disease specialist hospital
state: Qinghai
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Taiyuan
country: China
facility: Peking University First Hospital Taiyuan Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Beichen Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
Study officials:
References: