Hypertension, Resistant to Conventional Therapy
Conditions
Keywords
Renal denervation, Resistant hypertension, Spironolactone, Long-term Outcome
Brief summary
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.
Interventions
DEVICERenal denervation (Symplicity® Catheter System™)
4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)
Sponsors
General University Hospital, Prague
University Hospital Olomouc
Cardiocenter Podlesí, Trinec, Czech Republic
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure difference | 6 months | Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure differences similar to primary outcome | 1 year, 2 years, 3 years | Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office. |
| Change of blood laboratory parameters and renal function | 6 months, 1, 2, 3 years | changes in blood concentrations of renin, aldosterone, metanephrines and renal function |
| Post-denervation renal anatomy assessment | 1 year | CT angiography will be performed 1 year after RDN |
Countries
Czechia
Outcome results
None listed