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

Expanded access is no longer available for this treatment.
(Symplicity HTN-3 trial showed no benefit, hence trial was terminated)
Sponsor:
Collaborator:
National Heart Centre Singapore
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01747382
First received: December 9, 2012
Last updated: April 27, 2017
Last verified: April 2017
  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
Hypertension
Chronic Kidney Disease
Procedure: Renal denervation

Study Type: Expanded Access     What is Expanded Access?
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:

Study Start Date: April 2012
Estimated Study Completion Date: September 2017
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Renal denervation
    Other Name: Symplicity radiofrequency catheter
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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

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: April 27, 2017

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 May 23, 2017