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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 November 2015 |
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Main ID: |
NCT01673516 |
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Date of registration:
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17/08/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography
OsloRDN |
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Scientific title:
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Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01673516 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Norway
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Contacts
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Name:
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Aud Høieggen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension, Resistant to Conventional Therapy
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Intervention(s)
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Procedure: The SymplicityTM Renal Denervation System
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Device: The HOTMAN® System
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Primary Outcome(s)
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Absolute change in office systolic blood pressure(SBP)
[Time Frame: at 6 months]
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Secondary Outcome(s)
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Cost effectiveness
[Time Frame: At 6 month and later]
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Short and long term safety of RDN as an interventional procedure
[Time Frame: up to10 years]
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The normalization of hemodynamics.
[Time Frame: at 6 month and later]
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Percentage of normalization of blood pressure(BP) at office, home and ABPM
[Time Frame: at 6 months and later]
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Secondary ID(s)
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2012/145/REK
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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