Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

NCT ID: NCT01785732

Last Updated: 2013-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Resistant Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal denervation

Patients are randomized to renal denervation

Group Type ACTIVE_COMPARATOR

Renal Denervation

Intervention Type PROCEDURE

Sympathetic renal denervation via renal arteries

Optimization of medical therapy

Antihypertensive treatment is optimized

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Renal Denervation

Sympathetic renal denervation via renal arteries

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital District of Satakunta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Satakunta Central Hospital

Pori, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Tuomas Paana, M.D.

Role: CONTACT

+358 2 6277100

Antti Ylitalo, M.D. Ph.D

Role: CONTACT

+358 2 6277100

Facility Contacts

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Tuomas Paana, M.D

Role: primary

+358 2 6277100

Other Identifiers

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SA-007

Identifier Type: -

Identifier Source: org_study_id

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