TerminatedPhase 3

Renal Denervation in Refractory Hypertension

Stopped: Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.

Czechia106 participantsStarted 2011-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Blood pressure difference

Timeframe: 6 months

Trial details

NCT IDNCT01560312

SponsorCharles University, Czech Republic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

View on ClinicalTrials.gov More Hypertension trials