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

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. Identifier: NCT01747382
Expanded Access Status : No longer available (Symplicity HTN-3 trial showed no benefit, hence trial was terminated)
First Posted : December 11, 2012
Last Update Posted : May 2, 2017
National Heart Centre Singapore
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

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 or disease Intervention/treatment
Hypertension Chronic Kidney Disease Procedure: Renal denervation

Study Type : Expanded Access
Official Title: Catheter-based Renal Sympathetic Nerve Ablation for Treatment-resistant Hypertension in Patients With Chronic Kidney Disease
Study Start Date : April 2012
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Intervention Details:
  • Procedure: Renal denervation
    Other Name: Symplicity radiofrequency catheter

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01747382

National Heart Centre of Singapore
Singapore, Singapore, 168752
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
National Heart Centre Singapore
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

Responsible Party: Singapore General Hospital Identifier: NCT01747382     History of Changes
Other Study ID Numbers: NKFRC/2011/07/26
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

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

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