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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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19 February 2015 |
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Main ID: |
NCT01785732 |
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Date of registration:
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05/02/2013 |
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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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Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
RENSYMPIS |
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Scientific title:
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Date of first enrolment:
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January 2013 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01785732 |
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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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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Tuomas Paana, M.D. |
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Address:
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Telephone:
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+358 2 6277100 |
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Email:
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tuomas.paana@satshp.fi |
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Affiliation:
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Name:
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Tuomas Paana, M.D |
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Address:
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Telephone:
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+358 2 6277100 |
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Email:
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tuomas.paana@satshp.fi |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Resistant Hypertension (systolic blood pressure >160mmHg and 3 or more
antihypertensive agents in use)
- Age 30- 69 years
- Written informed consent
Exclusion Criteria:
- Secondary hypertension
- Pseudohypertension
- Pregnancy
- Renal insufficiency (GFR <45ml/min)
- Clinically significant stenotic valvular disease
- Oral anticoagulation
- CCS III-IV symptoms or CABG/PCI in previous 6 months
- Prior stroke
- Contrast agent allergy
- inappropriate renal artery anatomy (< 4mm diameter, < 20mm length)
Age minimum:
30 Years
Age maximum:
69 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Resistant Hypertension
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Intervention(s)
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Procedure: Renal Denervation
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Primary Outcome(s)
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Office blood pressure
[Time Frame: 2 years]
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Secondary Outcome(s)
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Endothelial function
[Time Frame: 2 years]
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Insulin resistance
[Time Frame: 2 years]
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Ambulatory blood pressure
[Time Frame: 2 years]
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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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