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Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study) (RENSYMPIS)

Primary Purpose

Resistant Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
The Hospital District of Satakunta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistant Hypertension

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Satakunta Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Renal denervation

Optimization of medical therapy

Arm Description

Patients are randomized to renal denervation

Antihypertensive treatment is optimized

Outcomes

Primary Outcome Measures

Office blood pressure

Secondary Outcome Measures

Ambulatory blood pressure
Insulin resistance
Endothelial function

Full Information

First Posted
February 5, 2013
Last Updated
February 8, 2013
Sponsor
The Hospital District of Satakunta
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1. Study Identification

Unique Protocol Identification Number
NCT01785732
Brief Title
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
Acronym
RENSYMPIS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hospital District of Satakunta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Cardiovascular function Metabolic factors Inflammatory and endocrine factors Coagulation Sleep

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Active Comparator
Arm Description
Patients are randomized to renal denervation
Arm Title
Optimization of medical therapy
Arm Type
No Intervention
Arm Description
Antihypertensive treatment is optimized
Intervention Type
Procedure
Intervention Name(s)
Renal Denervation
Intervention Description
Sympathetic renal denervation via renal arteries
Primary Outcome Measure Information:
Title
Office blood pressure
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Ambulatory blood pressure
Time Frame
2 years
Title
Insulin resistance
Time Frame
2 years
Title
Endothelial function
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuomas Paana, M.D.
Phone
+358 2 6277100
Email
tuomas.paana@satshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Antti Ylitalo, M.D. Ph.D
Phone
+358 2 6277100
Email
antti.ylitalo@satshp.fi
Facility Information:
Facility Name
Satakunta Central Hospital
City
Pori
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuomas Paana, M.D
Phone
+358 2 6277100
Email
tuomas.paana@satshp.fi
First Name & Middle Initial & Last Name & Degree
Tuomas Paana, M.D.
First Name & Middle Initial & Last Name & Degree
Antti Ylitalo, M.D. Ph.D
First Name & Middle Initial & Last Name & Degree
Risto Kaaja, M.D. Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

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