Renal Denervation in Refractory Hypertension

Phase 3TerminatedNCT01560312

Charles University, Czech Republic106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Hypertension Resistant to Conventional Therapy

Interventions

Renal denervation (Symplicity® Catheter System™)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Cardiocenter, University Hospital Olomouc

Olomouc, Czechia

Jiri Widimsky

Prague, Czechia

Cardiocenter Podlesi

Třinec, Czechia

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 6 months, 1, 2, 3 years

Post-denervation renal anatomy assessment

CT angiography will be performed 1 year after RDN

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.