Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

This study is currently recruiting participants.
Verified February 2013 by The Hospital District of Satakunta
Sponsor:
Information provided by (Responsible Party):
The Hospital District of Satakunta
ClinicalTrials.gov Identifier:
NCT01785732
First received: February 5, 2013
Last updated: February 8, 2013
Last verified: February 2013

February 5, 2013
February 8, 2013
January 2013
January 2014   (final data collection date for primary outcome measure)
Office blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01785732 on ClinicalTrials.gov Archive Site
  • Ambulatory blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Insulin resistance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
Not Provided

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Resistant Hypertension
Procedure: Renal Denervation
Sympathetic renal denervation via renal arteries
  • Active Comparator: Renal denervation
    Patients are randomized to renal denervation
    Intervention: Procedure: Renal Denervation
  • No Intervention: Optimization of medical therapy
    Antihypertensive treatment is optimized
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2016
January 2014   (final data collection date for primary outcome measure)

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)
Both
30 Years to 69 Years
No
Contact: Tuomas Paana, M.D. +358 2 6277100 tuomas.paana@satshp.fi
Contact: Antti Ylitalo, M.D. Ph.D +358 2 6277100 antti.ylitalo@satshp.fi
Finland
 
NCT01785732
SA-007
Yes
The Hospital District of Satakunta
The Hospital District of Satakunta
Not Provided
Not Provided
The Hospital District of Satakunta
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP