Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 19 and 79 years old (male or female)
• People who have high blood pressure that has not been controlled despite taking at least 3 different types of blood pressure medications (including a water tablet/diuretic) on a stable dose for at least 4 weeks before the first screening visit
• People whose blood pressure readings remain high at both screening visits — specifically, the top number (systolic) must be 140 mmHg or above and the bottom number (diastolic) must be 90 mmHg or above in the clinic, and a daytime average systolic reading of 135 mmHg or above on a monitoring device at the second screening visit
• People who are willing to keep taking their existing blood pressure medications throughout the run-in period and for at least 3 months after the procedure
• People who are able and willing to give written consent to take part in the trial

Who may not be able to join:

• People whose kidney arteries have certain structural problems found on a CT scan — such as fatty deposits or an artery stent within 5mm of the treatment site, significant narrowing (30% or more) of the available blood vessels, or cases where the treating doctor determines the procedure cannot be performed on both kidney arteries
• People with a history of previous renal denervation treatment, kidney artery stenting within 3 months before the procedure, polycystic kidney disease, a shrunken (atrophic) kidney, a kidney transplant, dialysis for end-stage kidney disease, any surgery on both kidneys, or a condition called fibromuscular dysplasia
• People who have previously had surgery using the retroperitoneal approach (a specific surgical pathway near the kidneys), or who have scarring or inflammation in that area of the body
• People with a very high BMI (body mass index over 40 kg/m²)
• People considered at risk of raised pressure in the skull (confirm with trial site)
• People whose kidneys are not functioning well enough — specifically, those with a kidney filtration rate (eGFR) below 45 mL/min/1.73m²
• People with type 1 diabetes, or type 2 diabetes that is not well controlled (HbA1c of 8.0% or higher)
• People who have taken certain diabetes medications called SGLT2 inhibitors or GLP-1 agonists within 90 days before the first screening visit, or who are expected to need them during the trial — unless they have been on the same continuous dose for more than 90 days without any changes
• People who experience a significant drop in blood pressure when standing up (a drop of 20 mmHg or more in the top number, or 10 mmHg or more in the bottom number, with symptoms) — unless the treating doctor confirms this is clearly caused by a benign prostate condition
• People the treating doctor considers at risk of dangerous blood pressure drops, for example those with heart valve narrowing, peripheral vascular disease, aortic aneurysm, or serious bleeding risks such as very low platelets, haemophilia, or severe anaemia
• People whose blood pressure is difficult to measure accurately — for example, due to arm size being too large for the cuff, or an irregular heartbeat (arrhythmia)
• People whose high blood pressure is caused by another underlying medical condition (secondary hypertension), or who are taking medications that stimulate the sympathetic nervous system and affect blood pressure
• People who have had a heart attack, angina (stable or unstable), severe heart failure (NYHA Class III–IV), a mini-stroke (TIA), or a serious brain blood vessel event (such as subarachnoid haemorrhage or cerebral embolism) within 3 months before the first screening visit
• People with atrial fibrillation (irregular heartbeat), unless sinus rhythm has been confirmed after medication or a procedure such as catheter ablation
• People with primary pulmonary hypertension (high blood pressure in the lungs)
• People with confirmed bleeding disorders, clotting problems, or who refuse blood transfusions
• People with a history of peptic ulcer disease or gastrointestinal bleeding within 6 months before the first screening visit
• People who rely on ongoing oxygen support or mechanical breathing assistance (such as CPAP or BiPAP) — except when this is used only for sleep apnoea
• People who have used anti-inflammatory pain medications (NSAIDs) twice or more per week within 1 month before the second screening visit
• People with a history of severe reactions to contrast dye (used in scans), or uncontrolled allergies
• People receiving antiretroviral medications for HIV, unless there is documented evidence that their high blood pressure existed before starting that treatment
• People with a history of narcotic drug abuse, those currently using methadone, or those who have used narcotic drugs two or more times within 1 month before the first screening visit
• People with current drug or alcohol dependence who are unable to understand or follow the trial requirements
• People who are scheduled for another surgery or procedure that the treating doctor believes could affect the trial results or safety
• People who work night shifts
• People who have taken part in another clinical trial (using an investigational drug or device) within 4 weeks before the first screening visit — unless the treating doctor determines there is no impact on this trial's assessments
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period
• Anyone else the treating doctor considers unsuitable for the trial

Important: Always verify eligibility with the trial site directly before applying.