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RAFALE: Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control

Sponsor
Mei changlin (Other)
Overall Status
Unknown status
CT.gov ID
NCT01932450
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
23
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: renal sympathetic denervation
  • Drug: antihypertensive drugs
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Aug 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

    Outcome Measures

    Primary Outcome Measures

    1. office-based measurements of systolic blood pressure [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.

    Secondary Outcome Measures

    1. 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) [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.

    2. Incidence of office systolic blood pressure reduction [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.

    3. office diastolic blood pressure [baseline and 12 months (day 360±14)]

      Change in office diastolic blood pressure from baseline to 12 months.

    4. number and dosage of blood pressure tablets [baseline and 12 months (day 360±14)]

      Change in number and dosage of blood pressure tablets from baseline to 12 months.

    5. estimated Glomerular Filtration Rate(eGFR) [baseline and 12 months (day 360±14)]

      Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.

    6. albuminuria [baseline and 12 months (day 360±14)]

      Change in albuminuria from baseline to 12 months.

    7. total kidney volume (TKV) [baseline and 12 months (day 360±14)]

      Change in total kidney volume (TKV) from baseline to 12 months

    8. pain [baseline and 12 months (day 360±14)]

      Change in pain related to cystic kidneys from baseline to 12 months.

    9. procedure-related complications at femoral puncture site [up to 1 year (after radiofrequency ablation)]

      Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).

    10. Renal artery lesion [up to 1 year (after radiofrequency ablation)]

      Renal artery lesion (perforation or dissection).

    11. New renal artery stenosis [up to 1 year (after radiofrequency ablation)]

      New renal artery stenosis >70%, determined by MRI within 12 months of randomization.

    12. Embolic events [up to 1 year (after radiofrequency ablation)]

      Embolic events.

    13. hypotension [up to 1 year (after radiofrequency ablation)]

      Episodes of hypotension.

    14. hypertension. [up to 1 year (after radiofrequency ablation)]

      Episodes of hypertension.

    15. acute kidney injury [up to 1 year (after radiofrequency ablation)]

      Acute deterioration of renal function

    16. total cyst volume (TCV) [baseline and 12 months (day 360±14)]

      Change in total cyst volume (TCV) from baseline to 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Department of Nephrology, Shanghai Changzheng Hospital Shanghai Shanghai China 200003

    Sponsors and Collaborators

    • Mei changlin

    Investigators

    • Principal Investigator: Changlin Mei, MD, Nephrology Department of Shanghai Changzheng Hospital

    Study Documents (Full-Text)

    None provided.

    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
    Other Study ID Numbers:
    • CZKIPLA-ADPKD-001
    First Posted:
    Aug 30, 2013
    Last Update Posted:
    Sep 25, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Mei changlin, Chief Physician, Professor, The director of Nephrology department and Internal Medicine department, Shanghai Changzheng Hospital
    hypertension
    radiofrequency ablation
    autosomal dominant polycystic kidney disease
    Additional relevant MeSH terms:
    Arthrogryposis
    Kidney Diseases
    Polycystic Kidney Diseases
    Polycystic Kidney, Autosomal Dominant
    Hypertension
    Disease Progression
    Antihypertensive Agents

    Study Results

    No Results Posted as of Sep 25, 2014