Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography (OsloRDN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01673516
First received: August 17, 2012
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN) improves the control of blood pressure (BP) in patients with treatment-resistant hypertension, as compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) during 6 months intensive treatment program (receiving antihypertensive care according to the 2007 ESH Guidelines). Working hypothesis: When it is possible to disrupt the sympatho-renal axis by RDN - BP reduction occurs to a greater extent and more rapidly than applying intensive medical therapy using IHM.


Condition Intervention Phase
Hypertension, Resistant to Conventional Therapy
Procedure: The SymplicityTM Renal Denervation System
Device: The HOTMAN® System
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: Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Absolute change in office systolic blood pressure(SBP) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    is the absolute change in office SBP, after a 6 months follow-up.


Secondary Outcome Measures:
  • Short and long term safety of RDN as an interventional procedure [ Time Frame: up to10 years ] [ Designated as safety issue: Yes ]
    Safety of RDN will be assessed at 1, 3, 5 and 10 years by clinical, laboratory and radiology examinations.

  • Percentage of normalization of blood pressure(BP) at office, home and ABPM [ Time Frame: at 6 months and later ] [ Designated as safety issue: No ]
    This will include the percentage of normalization of daytime SBP at office, home and ABPM.

  • The normalization of hemodynamics. [ Time Frame: at 6 month and later ] [ Designated as safety issue: No ]
    The normalization of hemodynamics: Cardiac Index (CI), Heart rate, Stroke systemic vascular resistance index (SSVRI), pulse wave velocity(PWV) and central BP.

  • Cost effectiveness [ Time Frame: At 6 month and later ] [ Designated as safety issue: No ]
    It will be assessed the Cost effectiveness of Renal denervation as treatment of resistant hypertension compared to control group.


Other Outcome Measures:
  • The quality of life and side effects related to antihypertensive agents [ Time Frame: at 6 months and later ] [ Designated as safety issue: Yes ]
    The quality of life and side effects related to antihypertensive agents


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group Co
group Co receives intensive medical therapy utilizing integrated hemodynamic management calculated by impedance cardiography of "The HOTMAN® System"
Device: The HOTMAN® System
Impedance Cardiography by HOTMAN system will evaluates non-invasively hemodynamic parameters in patients randomized to "group Co"
Active Comparator: group RDN
For patients who will be randomly assigned to undergo renal denervation by "The SymplicityTM Renal Denervation System", the femoral artery will be accessed with the standard endovascular technique and the catheter will be advanced into the renal artery and connected to a radiofrequency generator. As in Symplicity HTN 1 and 2 trials, four-to-six discrete, low-power radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to four-six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
Procedure: The SymplicityTM Renal Denervation System
For patients who will be randomly assigned to undergo renal denervation (group RDN), the femoral artery will be accessed with the standard endovascular technique and the catheter will be advanced into the renal artery and connected to a radiofrequency generator. As in Simplicity HTN 1 and 2 trials, four-to-six discrete, low-power radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to four-six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Average SBP >140mmHg, measured per guidelines
  • 24 hour average ABPM daytime SBP >135mm/Hg
  • On stable medication regimen of full tolerated doses of 3 or more antihypertensive meds, with one being a diuretic
  • No changes for a minimum of 2 weeks prior to screening
  • No planned medication changes for 6 months
  • Age 18-80 years
  • At minimum, 3 antihypertensive medications must meet one or more of the following full dose criteria:
  • Highest labeled dose according to medication's labeling
  • Highest usual dose per clinical guidelines-JNC-7
  • Highest tolerated dose
  • Highest appropriate dose for the patient per the PI's clinical judgment

Exclusion Criteria:

  • Hemodynamically or anatomically significant renal artery abnormalities or stenosis >50% or prior renal artery intervention
  • eGFR < 45 mL/min/1.73m2 (MDRD formula)
  • Albumin/creatinine ratio > 50 mg/mmol
  • Type 1 diabetes mellitus
  • Known alcohol or drug abuse
  • Symptomatic orthostatic hypotension in past year
  • Stenotic valvular heart disease for which BP reduction would be hazardous
  • MI, unstable angina, or CVA in the prior 6 months
  • Known primary pulmonary HTN
  • Known pheochromocytoma, Cushing's disease, coarctation of the aorta, hyperthyroidism or hyperparathyroidism
  • Known primary hyperaldosteronism not adequately treated.
  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: NCT01673516

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Chair: Aud Høieggen, MD, PhD Oslo University Hospital
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01673516     History of Changes
Other Study ID Numbers: 2012/145/REK
Study First Received: August 17, 2012
Last Updated: December 13, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Renal sympathetic denervation
Impedance cardiography

Additional relevant MeSH terms:
Hypertension
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on August 01, 2014