A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- office-based measurements of systolic blood pressure
研究概览
简要总结
A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys and renal function, will be assessed at 12 months of follow-up. The safety variables will be assessed at every visit of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ADPKD.
- •Having hypertension, defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, and currently using 2 antihypertensive drugs and receiving a stable antihypertensive treatment regimen without change in dose or medication in the previous 30 days.
- •Male and female patients 20 years to 60 years of age.
- •Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2, estimated from serum creatinine using the Chronic Kidney Disease Epidemiology collaboration(CKD-EPI) equation.
- •Have followed-up kidney and cyst volume at least 6 months in Shanghai Changzheng Hospital.
- •Signed Informed Consent after being informed.
排除标准
- •Documented renal vascular disease.
- •Congenital absence of a kidney.
- •Systemic illness with renal involvement.
- •Spot urine albumin-to-creatinine ratio of >0.5 g/g and/or findings suggestive of kidney disease other than ADPKD.
- •Exclusions specific to MRI acquisition and measurement: cardiac pacemaker, presence of MRI incompatible metallic clips or other material, excessive body weight, untreatable claustrophobia.
- •Contraindications to the catheter-based renal denervation procedure by RFA, including allergy to radioiodinated contrast agents. Anatomical abnormalities of the renal arteries which preclude RFA: presence in either kidneys of multiple main renal arteries, main renal artery stenosis >50%, or main renal arteries of <4 mm in diameter or <20 mm in length.
- •Contraindications on ethical grounds.
- •Women who are pregnant or breast feeding.
- •Intention to become pregnant during the course of the study.
- •Lack of safe contraception: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential).
- •Other clinically significant concomitant disease states (hepatic dysfunction, cardiovascular disease, metastatic cancer).
- •Known or suspected non-compliance, drug or alcohol abuse.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
- •Previous enrolment into the current study.
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
研究组 & 干预措施
renal sympathetic denervation
One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
干预措施: renal sympathetic denervation (Procedure)
renal sympathetic denervation
One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
干预措施: antihypertensive drugs (Drug)
antihypertensive drugs
Blood pressure control in ADPKD patients with hypertension only using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB)
干预措施: antihypertensive drugs (Drug)
结局指标
主要结局
office-based measurements of systolic blood pressure
时间窗: baseline and 12 months (day 360±14)
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.
次要结局
- total kidney volume (TKV)(baseline and 12 months (day 360±14))
- Renal artery lesion(up to 1 year (after radiofrequency ablation))
- New renal artery stenosis(up to 1 year (after radiofrequency ablation))
- Embolic events(up to 1 year (after radiofrequency ablation))
- 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)(baseline and 12 months (day 360±14))
- pain(baseline and 12 months (day 360±14))
- office diastolic blood pressure(baseline and 12 months (day 360±14))
- hypertension.(up to 1 year (after radiofrequency ablation))
- Incidence of office systolic blood pressure reduction(baseline and 12 months (day 360±14))
- number and dosage of blood pressure tablets(baseline and 12 months (day 360±14))
- estimated Glomerular Filtration Rate(eGFR)(baseline and 12 months (day 360±14))
- albuminuria(baseline and 12 months (day 360±14))
- procedure-related complications at femoral puncture site(up to 1 year (after radiofrequency ablation))
- hypotension(up to 1 year (after radiofrequency ablation))
- acute kidney injury(up to 1 year (after radiofrequency ablation))
- total cyst volume (TCV)(baseline and 12 months (day 360±14))
研究者
Mei changlin
Chief Physician, Professor, The director of Nephrology department and Internal Medicine department
Shanghai Changzheng Hospital