Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renovascular Hypertension Patients: a Pilot Randomized Trial

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test, Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Chao-yang hospital, capital medical university
RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Peking University First Hospital Taiyuan Hospital
RECRUITING
Taiyuan
Tianjin Beichen Hospital
RECRUITING
Tianjin
Tianjin First Central Hospital
RECRUITING
Tianjin
Qinghai province cardiovascular and cerebrovascular disease specialist hospital
RECRUITING
Xining
Zibo Central Hospital
RECRUITING
Zibo
Contact Information
Primary
Yuxi Li, MD
liyuxi@pku.edu.cn
00861083572283
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 100
Treatments
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.
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.
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov