Renal Denervation for Treatment of Resistant Hypertension in Patients With Chronic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Singapore General Hospital
Sponsor:
Collaborators:
National Heart Centre of Singapore Pte Ltd
National Kidney Foundation, Singapore
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01747382
First received: December 9, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

Recent clinical studies have demonstrated that catheter-based renal sympathetic nerve ablation is safe and effective in treating patients with resistant hypertension. However, there is limited data on its safety and efficacy in patients with Chronic Kidney Disease.

The investigators hypothesize that catheter-based renal sympathetic nerve ablation is safe and effective in the treatment of resistant hypertension in patients with Chronic Kidney Disease.


Condition Intervention Phase
Hypertension
Chronic Kidney Disease
Procedure: Renal denervation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter-based Renal Sympathetic Nerve Ablation for Treatment-resistant Hypertension in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Blood pressure measurements [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Office blood pressure measurements and 24 hour ambulatory blood pressure recordings will be taken at 1, 3, 6 and 12 months after renal denervation. The number of anti-hypertensive medications will also be recorded


Secondary Outcome Measures:
  • Renal function [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Serum creatinine and urine protein creatinine ratio will be measured at baseline and 1, 3, 6 and 12 months after the denervation procedure.


Other Outcome Measures:
  • Major procedural related complications [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]

    Major procedural related complication include:

    Renal artery dissection, perforation or pseudoaneurysm Femoral artery pseudoaneurysm, dissection, hematoma Bleeding, requiring transfusion



Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal denervation
Renal denervation using Symplicity radiofrequency catheter
Procedure: Renal denervation
Other Name: Symplicity radiofrequency catheter

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics).
  2. Individual is adhering to a stable drug regimen including 3 or more anti-hypertensive medications, of which one is a diuretic, (with no changes for a minimum of 2 weeks prior to enrollment) and is expected to be maintained for at least 6 months.
  3. Individual with stage 3 chronic kidney disease, defined as having an eGFR of 30 - 60 mL/min/1.73m2, using the MDRD calculation.
  4. Individual is ≥ 21 and ≤ 65 years of age.
  5. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

  1. Individual has renal artery anatomy that is ineligible for treatment including:

    1. Main renal arteries < 4 mm in diameter or < 20 mm in length.
    2. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation.
    3. A history of prior renal artery intervention including balloon angioplasty or stenting.
    4. Multiple main renal arteries in either kidney.
  2. Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
  3. Individual has type 1 diabetes mellitus.
  4. Individual has experienced a myocardial infarction, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
  5. Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
  6. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
  7. Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI).
  8. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
  9. Individual is pregnant, nursing or planning to be pregnant. [Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.]
  10. Individual is currently enrolled in another investigational drug or device trial.
  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: NCT01747382

Contacts
Contact: Chieh Suai Tan, M.B.B.S +65-63214436 tan.chieh.suai@sgh.com.sg
Contact: Soo Tiek Lim, M.B.B.S +65-64367521 lim.soo.teik@nhcs.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Sub-Investigator: Choong Meng Chan, M.B.B.S         
Sub-Investigator: Jason Chon Jun Choo, M.B.B.S         
Sub-Investigator: Darren Kian Guan Lee, M.B.B.S         
National Heart Centre of Singapore Recruiting
Singapore, Singapore, 168752
Principal Investigator: Soo Teik Lim, M.B.B.S         
Sub-Investigator: Chee Tang Chin, M.B.B.S         
Sponsors and Collaborators
Singapore General Hospital
National Heart Centre of Singapore Pte Ltd
National Kidney Foundation, Singapore
Investigators
Principal Investigator: Chieh Suai Tan, M.B.B.S Singapore General Hospital
Principal Investigator: Soo Teik Lim, M.B.B.S National Heart Centre of Singapore
  More Information

No publications provided

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01747382     History of Changes
Other Study ID Numbers: NKFRC/2011/07/26
Study First Received: December 9, 2012
Last Updated: December 10, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:
Treatment-resistant Hypertension
Chronic Kidney Disease
Symplicity catheters
Renal denervation

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 01, 2014