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 range

18 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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