Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

The Hospital District of Satakunta

Status: Unknown

Conditions: Resistant Hypertension

Treatments: Procedure: Renal Denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01785732

SA-007

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 69 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Renal denervation

Active Comparator group

Description:

Patients are randomized to renal denervation

Treatment:

Procedure: Renal Denervation

Optimization of medical therapy

No Intervention group

Description:

Antihypertensive treatment is optimized