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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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16 December 2017 |
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Main ID: |
NCT01850901 |
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Date of registration:
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21/03/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension
SYMPATHY |
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Scientific title:
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Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension - A Multicenter Randomized Controlled Trial |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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139 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01850901 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Netherlands
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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.
2. Individual is =18 years of age.
Exclusion Criteria:
1. Individual is unable or unwilling to sign informed consent.
2. Individual has a treatable secondary cause of hypertension.
3. Individual has an eGFR below 20 mL/min/1.73m2 using the Modification of Diet in Renal
Disease (MDRD) calculation.
4. Individual has renal artery anatomy that is ineligible for treatment
5. 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.
6. Individual is pregnant, nursing or planning to be pregnant.
7. 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.
8. Individual is currently enrolled in another investigational drug or device trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Hypertension
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Intervention(s)
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Procedure: Renal sympathetic denervation
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Primary Outcome(s)
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Change in BP (measured by ABPM)
[Time Frame: 6 months]
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Secondary Outcome(s)
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Change in the amount of antihypertensive medication
[Time Frame: 6 months]
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Change in office BP
[Time Frame: 6 months]
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Change in BP in eGFR strata
[Time Frame: 6 months]
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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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