Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension (NCT01499810) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
Russia53 participantsStarted 2010-03
Plain-language summary
Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic. Bilateral transcatheter renal denervation will be performed on the top of existed pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of follow-up.
Who can participate
Age range
18 Years – 80 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:
* Age ≥ 18 and ≤ 80 years at time of randomization
* Informed consent
* Treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
* Office Systolic BP (SBP) ≥ 160 mmHg or Diastolic BP (DBP) ≥ 100 mmHg
Exclusion Criteria:
* An estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2
* Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg or DBP \< 85 mmHg
* Symptomatic(secondary) hypertension
* Severe renal artery stenosis or renal arteries abnormalities
* Individual is pregnant, nursing or planning to be pregnant
* Severe hepatic dysfunction
* Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
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
1
Change in Office Systolic BP
Timeframe: from baseline to 12 months
2
Number of Serious Adverse Events
Timeframe: from baseline to 12 months
Trial details
NCT IDNCT01499810
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences