Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

Resistant Hypertension Clinical Trial

— RENSYMPIS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01785732
• Other study ID #: SA-007
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2013
• Last updated: February 8, 2013
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2013
• Source: The Hospital District of Satakunta
• Contact: Tuomas Paana, M.D.
• Phone: +358 2 6277100
• Email: tuomas.paana[@]satshp.fi
• Is FDA regulated: No
• Health authority: Finland: Institutional review board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Resistant Hypertension

Intervention

Procedure:
• Renal Denervation
Sympathetic renal denervation via renal arteries

Locations

Country	Name	City	State
Finland	Satakunta Central Hospital	Pori

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital District of Satakunta

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Office blood pressure		2 years	No
Secondary	Ambulatory blood pressure		2 years	No
Secondary	Insulin resistance		2 years	No
Secondary	Endothelial function		2 years	No