Status:
COMPLETED
Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Medtronic
Conditions:
Hypertension
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after ...
Eligibility Criteria
Inclusion
- Individual has a mean day-time SBP ≥ 135 mmHg, as determined with the use of ABPM, while using 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs ( ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti-hypertensive drugs.
- Individual is ≥18 years of age.
Exclusion
- Individual is unable or unwilling to sign informed consent.
- Individual has a treatable secondary cause of hypertension.
- Individual has an eGFR below 20 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) calculation.
- Individual has renal artery anatomy that is ineligible for treatment
- 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.
- Individual is pregnant, nursing or planning to be pregnant.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT01850901
Start Date
May 1 2013
End Date
December 1 2016
Last Update
February 1 2017
Active Locations (1)
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1
UMC Utrecht
Utrecht, Netherlands