Renal Sympathetic Denervation and Insulin Sensitivity (RE... | NCT01785732

Studies
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

NCT01785732

Sponsor

The Hospital District of Satakunta

Status

Unknown status

Last Update Posted

Feb 11, 2013Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Resistant Hypertension

Interventions

Renal Denervation

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Feb 5, 2013

First Submission Date that Met QC Criteria

Feb 5, 2013

First Posted Date

Feb 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2013

Last Update Posted Date

Feb 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal denervation	Active Comparator	Patients are randomized to renal denervation	Procedure: Renal Denervation
Optimization of medical therapy	No Intervention	Antihypertensive treatment is optimized

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal Denervation	Procedure	Sympathetic renal denervation via renal arteries	Renal denervation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Office blood pressure		2 years

Secondary Outcomes

Measure	Description	Time Frame
Ambulatory blood pressure		2 years
Insulin resistance		2 years
Endothelial function

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tuomas Paana, M.D.	Contact	+358 2 6277100		tuomas.paana@satshp.fi
Antti Ylitalo, M.D. Ph.D	Contact	+358 2 6277100		antti.ylitalo@satshp.fi

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Satakunta Central Hospital	Recruiting	Pori			Finland