Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

• Sponsor: The Hospital District of Satakunta (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01785732
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.7

Study Details

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:

1. Cardiovascular function

2. Metabolic factors

3. Inflammatory and endocrine factors

4. Coagulation

5. Sleep

Condition or Disease	Intervention/Treatment	Phase
Resistant Hypertension	Procedure: Renal Denervation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Jan 1, 2014
• Anticipated Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Renal denervation Patients are randomized to renal denervation	Procedure: Renal Denervation; Sympathetic renal denervation via renal arteries
No Intervention: Optimization of medical therapy Antihypertensive treatment is optimized

Outcome Measures

Primary Outcome Measures

1. Office blood pressure [2 years]

Secondary Outcome Measures

1. Ambulatory blood pressure [2 years]

2. Insulin resistance [2 years]

3. Endothelial function [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Satakunta Central Hospital	Pori		Finland

Sponsors and Collaborators

• The Hospital District of Satakunta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Hospital District of Satakunta
• ClinicalTrials.gov Identifier: NCT01785732
• Other Study ID Numbers: SA-007
• First Posted: Feb 7, 2013
• Last Update Posted: Feb 11, 2013
• Last Verified: Feb 1, 2013

• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Feb 11, 2013