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Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control (RAFALE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Mei changlin, Shanghai Changzheng Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01932450
First Posted: August 30, 2013
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mei changlin, Shanghai Changzheng Hospital
August 18, 2013
August 30, 2013
September 25, 2014
August 2013
December 2014   (Final data collection date for primary outcome measure)
office-based measurements of systolic blood pressure [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01932450 on ClinicalTrials.gov Archive Site
  • 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
  • Incidence of office systolic blood pressure reduction [ Time Frame: baseline and 12 months (day 360±14) ]
    Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
  • office diastolic blood pressure [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in office diastolic blood pressure from baseline to 12 months.
  • number and dosage of blood pressure tablets [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in number and dosage of blood pressure tablets from baseline to 12 months.
  • estimated Glomerular Filtration Rate(eGFR) [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
  • albuminuria [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in albuminuria from baseline to 12 months.
  • total kidney volume (TKV) [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in total kidney volume (TKV) from baseline to 12 months
  • pain [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in pain related to cystic kidneys from baseline to 12 months.
  • procedure-related complications at femoral puncture site [ Time Frame: up to 1 year (after radiofrequency ablation) ]
    Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
  • Renal artery lesion [ Time Frame: up to 1 year (after radiofrequency ablation) ]
    Renal artery lesion (perforation or dissection).
  • New renal artery stenosis [ Time Frame: up to 1 year (after radiofrequency ablation) ]
    New renal artery stenosis >70%, determined by MRI within 12 months of randomization.
  • Embolic events [ Time Frame: up to 1 year (after radiofrequency ablation) ]
    Embolic events.
  • hypotension [ Time Frame: up to 1 year (after radiofrequency ablation) ]
    Episodes of hypotension.
  • hypertension. [ Time Frame: up to 1 year (after radiofrequency ablation) ]
    Episodes of hypertension.
  • acute kidney injury [ Time Frame: up to 1 year (after radiofrequency ablation) ]
    Acute deterioration of renal function
  • total cyst volume (TCV) [ Time Frame: baseline and 12 months (day 360±14) ]
    Change in total cyst volume (TCV) from baseline to 12 months
Same as current
Not Provided
Not Provided
 
Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Autosomal Dominant Polycystic Kidney Disease
  • Hypertension
  • Procedure: renal sympathetic denervation
    One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
    Other Names:
    • Percutaneous radiofrequency ablation of renal nerves
    • Transcatheter renal denervation
    • renal denervation
    • renal ablation
  • Drug: antihypertensive drugs
    antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.
  • Experimental: 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).
    Interventions:
    • Procedure: renal sympathetic denervation
    • Drug: antihypertensive drugs
  • Active Comparator: 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)
    Intervention: Drug: antihypertensive drugs

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
July 2015
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01932450
CZKIPLA-ADPKD-001
Yes
Not Provided
Not Provided
Mei changlin, Shanghai Changzheng Hospital
Mei changlin
Not Provided
Principal Investigator: Changlin Mei, MD Nephrology Department of Shanghai Changzheng Hospital
Shanghai Changzheng Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP