Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

Not Applicable

• Conditions: Resistant Hypertension

• 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

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11
• Primary Completion: 2014-01
• Study Completion: 2016-01

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

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