Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control

Hypertension Clinical Trial

— RAFALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01932450
• Other study ID #: CZKIPLA-ADPKD-001
• Status: Recruiting
• Phase: Phase 2
• First received: August 18, 2013
• Last updated: September 23, 2014
• Start date: August 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2014
• Source: Shanghai Changzheng Hospital
• Contact: Changlin Mei, MD
• Phone: +86 21 81885391
• Email: chlmei1954[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Disease Progression
• Hypertension
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Procedure:
• renal sympathetic denervation
One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.

Drug:
• antihypertensive drugs
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.

Locations

Country	Name	City	State
China	Department of Nephrology, Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Mei changlin

Country where clinical trial is conducted

China, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	office-based measurements of systolic blood pressure	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.	baseline and 12 months (day 360±14)	No
Secondary	24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)	Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.	baseline and 12 months (day 360±14)	No
Secondary	Incidence of office systolic blood pressure reduction	Incidence of office systolic blood pressure reductions of =10, =15 and =20 mm Hg from baseline to 12 month.	baseline and 12 months (day 360±14)	No
Secondary	office diastolic blood pressure	Change in office diastolic blood pressure from baseline to 12 months.	baseline and 12 months (day 360±14)	No
Secondary	number and dosage of blood pressure tablets	Change in number and dosage of blood pressure tablets from baseline to 12 months.	baseline and 12 months (day 360±14)	No
Secondary	estimated Glomerular Filtration Rate(eGFR)	Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.	baseline and 12 months (day 360±14)	No
Secondary	albuminuria	Change in albuminuria from baseline to 12 months.	baseline and 12 months (day 360±14)	No
Secondary	total kidney volume (TKV)	Change in total kidney volume (TKV) from baseline to 12 months	baseline and 12 months (day 360±14)	No
Secondary	pain	Change in pain related to cystic kidneys from baseline to 12 months.	baseline and 12 months (day 360±14)	No
Secondary	procedure-related complications at femoral puncture site	Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).	up to 1 year (after radiofrequency ablation)	Yes
Secondary	Renal artery lesion	Renal artery lesion (perforation or dissection).	up to 1 year (after radiofrequency ablation)	Yes
Secondary	New renal artery stenosis	New renal artery stenosis >70%, determined by MRI within 12 months of randomization.	up to 1 year (after radiofrequency ablation)	Yes
Secondary	Embolic events	Embolic events.	up to 1 year (after radiofrequency ablation)	Yes
Secondary	hypotension	Episodes of hypotension.	up to 1 year (after radiofrequency ablation)	Yes
Secondary	hypertension.	Episodes of hypertension.	up to 1 year (after radiofrequency ablation)	Yes
Secondary	acute kidney injury	Acute deterioration of renal function	up to 1 year (after radiofrequency ablation)	Yes
Secondary	total cyst volume (TCV)	Change in total cyst volume (TCV) from baseline to 12 months	baseline and 12 months (day 360±14)	No