TerminatedPhase 2

Chemical Renal Ethanol Sympatholysis Under CT Guidance Use for the Control of Therapy-Resistant Hypertension

Stopped: patient recruitment is difficult

France2 participantsStarted 2016-02

Plain-language summary

In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance. To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted. The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.

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: * more or equal than 18 years old, * patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment: * in the last two months, * expected in the next three months, * renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation OR * chronic renal failure patient with dialysis and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation * patient affiliated to social security or similarly regime * patient who signed the consent to participate in the study No Inclusion Criteria: * renal artery anatomy against-indicating the procedure including: * 3 homolateral renal arteries * kidney surgery including bypass surgery or renal artery reimplantation * volume-dependent type of hypertension * secondary hypertension (not included nephropathy) * orthostatic hypotension associated with symptoms during the previous year * medical history including: * acute coronary syndrome, unstable angina, stroke within 6 months preceding the period of inclusion, * surgery scheduled on the kidney, the renal arteries or the retroperitoneum during patient participation in the study peri…

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

Success or failure of the peri-arterial technique injection of ethanol under CT guidance.

Timeframe: 2 hours

Trial details

NCT IDNCT02653222

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02

View on ClinicalTrials.gov More Hypertension Resistant to Conventional Therapy trials