Renal Denervation in Refractory Hypertension

Study Overview
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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.

Official Title
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Renal Denervation - Hope for Patients With Refractory Hypertension?

Conditions
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Hypertension, Resistant to Conventional Therapy

Intervention / Treatment
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* Device: Renal denervation (Symplicity® Catheter System™)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation<br>Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization) | Device: Renal denervation (Symplicity® Catheter System™)<br>* 4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)<br>|
| No Intervention: Medical treatment<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure difference | Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure differences similar to primary outcome | Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office. | 1 year, 2 years, 3 years | 
| Change of blood laboratory parameters and renal function | changes in blood concentrations of renin, aldosterone, metanephrines and renal function | 6 months, 1, 2, 3 years | 
| Post-denervation renal anatomy assessment | CT angiography will be performed 1 year after RDN | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal denervation, Resistant hypertension, Spironolactone, Long-term Outcome