Renal Denervation in Refractory Hypertension

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

Brief Summary

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Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.

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Detailed Description

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Conditions

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Hypertension Resistant to Conventional Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal denervation

Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization)

Group Type EXPERIMENTAL

Renal denervation (Symplicity® Catheter System™)

Intervention Type DEVICE

4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)

Medical treatment

Conventional antihypertensive treatment including spironolactone (if not contraindicated).

One year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Renal denervation (Symplicity® Catheter System™)

4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Refractory hypertension with office SBP \> 140 mmHg
* SBP \> 130 during 24-hours Holter blood pressure monitoring
* Treatment with the least 3 antihypertensive medications including diuretics in optimal doses
* Age \> 18 years
* Signed informed consent

Exclusion Criteria

* Secondary forms of hypertension
* Chronic renal disease (serum creatinine \> 200 umol/l)
* Pregnancy
* History of myocardial infarction or stroke in last 6 months
* Severe valvular stenotic disease
* Anatomic abnormalities and variants of renal artery including aneurysms, severe stenosis, reference diameter \< 4 mm or length \< 20 mm
* Increased bleeding risk (thrombocytopenia \< 50, INR \> 1.5)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No