Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
Not Applicable
- Conditions
- Resistant Hypertension
- Interventions
- Procedure: Renal Denervation
- Registration Number
- NCT01785732
- Lead Sponsor
- The Hospital District of Satakunta
- Brief Summary
Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.
The purpose of RENSYMPIS is to study the effects of renal denervation on:
1. Cardiovascular function
2. Metabolic factors
3. Inflammatory and endocrine factors
4. Coagulation
5. Sleep
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal denervation Renal Denervation Patients are randomized to renal denervation
- Primary Outcome Measures
Name Time Method Office blood pressure 2 years
- Secondary Outcome Measures
Name Time Method Ambulatory blood pressure 2 years Insulin resistance 2 years Endothelial function 2 years
Trial Locations
- Locations (1)
Satakunta Central Hospital
🇫🇮Pori, Finland