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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Shanghai Changzheng Hospital
Sponsor:
Information provided by (Responsible Party):
Mei changlin, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT01932450
First received: August 18, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease
Hypertension
Procedure: renal sympathetic denervation
Drug: antihypertensive drugs
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • office-based measurements of systolic blood pressure [ Time Frame: baseline and 12 months (day 360±14) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) [ Time Frame: baseline and 12 months (day 360±14) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.

  • albuminuria [ Time Frame: baseline and 12 months (day 360±14) ] [ Designated as safety issue: No ]
    Change in albuminuria from baseline to 12 months.

  • total kidney volume (TKV) [ Time Frame: baseline and 12 months (day 360±14) ] [ Designated as safety issue: No ]
    Change in total kidney volume (TKV) from baseline to 12 months

  • pain [ Time Frame: baseline and 12 months (day 360±14) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    Renal artery lesion (perforation or dissection).

  • New renal artery stenosis [ Time Frame: up to 1 year (after radiofrequency ablation) ] [ Designated as safety issue: Yes ]
    New renal artery stenosis >70%, determined by MRI within 12 months of randomization.

  • Embolic events [ Time Frame: up to 1 year (after radiofrequency ablation) ] [ Designated as safety issue: Yes ]
    Embolic events.

  • hypotension [ Time Frame: up to 1 year (after radiofrequency ablation) ] [ Designated as safety issue: Yes ]
    Episodes of hypotension.

  • hypertension. [ Time Frame: up to 1 year (after radiofrequency ablation) ] [ Designated as safety issue: Yes ]
    Episodes of hypertension.

  • acute kidney injury [ Time Frame: up to 1 year (after radiofrequency ablation) ] [ Designated as safety issue: Yes ]
    Acute deterioration of renal function

  • total cyst volume (TCV) [ Time Frame: baseline and 12 months (day 360±14) ] [ Designated as safety issue: No ]
    Change in total cyst volume (TCV) from baseline to 12 months


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
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)
Drug: antihypertensive drugs
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932450

Contacts
Contact: Changlin Mei, MD +86 21 81885391 chlmei1954@126.com
Contact: Yiyi Ma, Master +8613661679863 dukemm@126.com

Locations
China, Shanghai
Department of Nephrology, Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200003
Contact: Changlin Mei, MD    +862181885391    chlmei1954@126.com   
Contact: Yiyi Ma, Master    +8613661679863    dukemm@126.com   
Principal Investigator: Changlin Mei, MD         
Sub-Investigator: Shengqiang Yu, PHD         
Sub-Investigator: Lin Li, PHD         
Sub-Investigator: Xueqi Wang, PHD         
Sub-Investigator: Chenggang Xu, PHD         
Sub-Investigator: Zhiguo Mao, PHD         
Sub-Investigator: Bing Dai, PHD         
Sub-Investigator: Yiyi Ma, Master         
Sub-Investigator: Dongping Chen, Master         
Sponsors and Collaborators
Mei changlin
Investigators
Principal Investigator: Changlin Mei, MD Nephrology Department of Shanghai Changzheng Hospital
  More Information

Publications:

Responsible Party: Mei changlin, Chief Physician, Professor, The director of Nephrology department and Internal Medicine department, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT01932450     History of Changes
Other Study ID Numbers: CZKIPLA-ADPKD-001
Study First Received: August 18, 2013
Last Updated: August 27, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Changzheng Hospital:
hypertension
radiofrequency ablation
autosomal dominant polycystic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Hypertension
Disease Progression
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014