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 who have signed and dated a consent form agreeing to take part
• Adults aged between 22 and 75 years old at the time of signing consent
• People who have a documented diagnosis of high blood pressure (hypertension)
• People who have previously been prescribed, or are currently taking, medication to lower blood pressure
• People whose blood pressure readings at the first screening visit fall into one of two categories: either uncontrolled (between 140/90 and below 180/110 mmHg) while on 0–2 blood pressure medications for at least 4 weeks and willing to stop those medications for a washout period and 2 months after the procedure; or controlled (below 140/90 mmHg) while on 1–2 blood pressure medications for at least 4 weeks and willing to stop those medications for a washout period and 2 months after the procedure
• People who are able and willing to follow all study procedures
• People who are willing to undergo, and are considered a suitable candidate for, conscious sedation (a type of light sedation where a person is relaxed but awake)
• After the washout/run-in period, people whose daytime average blood pressure reading (measured by a monitor worn over the day) shows a top number of 135 mmHg or above and below 180 mmHg
• People whose kidney artery anatomy is confirmed as suitable for the procedure, based on a CT or MRI scan of the kidney arteries taken within the past year (or obtained as part of the study if no recent scan is available), with a final anatomy check performed in the procedure room before randomisation

Who may not be able to join:

• People who have been diagnosed with abnormal kidney artery anatomy, or who have a single kidney, a kidney located in an unusual position, horseshoe kidney, polycystic kidney disease, kidney tumours, or other findings that would prevent the procedure from being performed safely
• People who have an identified and uncorrected underlying cause of their high blood pressure — other than sleep apnea — such as certain hormonal conditions, kidney disease, adrenal gland problems, or thyroid disorders (confirm with trial site for full list)
• People with Type 1 diabetes, or Type 2 diabetes that is not well controlled (based on a blood test result of HbA1c of 9.0% or higher)
• People whose kidneys are not filtering blood well enough, based on a specific kidney function blood test result falling below a certain level (eGFR below 40 mL/min/1.73 m²)
• People who have had a stroke, mini-stroke, or similar brain-related blood vessel event in the 6 months before signing consent
• People who have had a serious heart event — such as a heart attack, unstable chest pain, heart bypass surgery, or severe heart failure requiring hospitalisation — within the 12 months before signing consent
• People who have severe narrowing or leaking of one or more heart valves
• People who have been hospitalised more than once for a hypertensive crisis (dangerously high blood pressure episode) in the past 12 months, or hospitalised for any hypertensive crisis in the 3 months before signing consent
• People who are taking certain blood pressure-related heart medications (such as beta blockers) for another ongoing condition, where stopping that medication could be a serious health risk in the investigator's opinion
• People who have rapid, uncontrolled, and symptomatic atrial fibrillation (an irregular and fast heartbeat causing symptoms)
• People who have an active implanted medical device, such as a defibrillator, cardiac resynchronisation device, nerve stimulator, spinal stimulator, or a device that stimulates pressure sensors in blood vessels
• People who require ongoing oxygen support or mechanical breathing assistance, other than a breathing device used at night for sleep apnea
• People who have a major surgery (requiring general anaesthesia) planned within the next 12 months
• People who are on blood-thinning medication that cannot safely be paused for the study procedure
• People who have primary pulmonary hypertension (high blood pressure specifically in the lungs that is not caused by another condition)
• People who have a known allergy or medical reason preventing the use of contrast dye (used during imaging), where that allergy cannot be treated or managed
• People who, in the investigator's opinion, have a life expectancy of less than 1 year
• People who regularly work night shifts
• People who have frequent or ongoing pain that requires them to take anti-inflammatory pain medications (such as ibuprofen or similar NSAIDs) on two or more days per week over the month before joining the trial
• People who are taking medication that suppresses the immune system for a condition that causes blood vessel inflammation
• People with a known history of drug or alcohol dependency, or anyone the investigator believes would be unable or unlikely to follow the study requirements for any reason, or whose participation could affect the reliability of study results
• People who are pregnant, breastfeeding, or planning to become pregnant within 12 months after the procedure; women who could become pregnant must have a negative pregnancy test documented within 7 days before the procedure, and must also provide documentation of effective contraception
• People who have a major surgery or heart-related procedure planned within the next 6 months
• People who have previously had a kidney transplant
• People who have signs of an active infection within 7 days of the procedure (confirmed by a lab test and requiring treatment)
• People who have hypertrophic cardiomyopathy (a thickened heart muscle condition) or amyloidosis (a condition where abnormal proteins build up in organs)
• People who have previously undergone a renal denervation procedure (the same type of procedure being studied in this trial)
• People who are currently enrolled in another clinical trial involving an investigational drug or device (taking part in non-treatment studies or patient registries is acceptable)
• People who are taking a beta blocker medication for a reason other than treating high blood pressure
• People whose kidney artery scans show certain features that make the procedure unsafe or unsuitable, including arteries that are too narrow or too short, certain artery abnormalities, significant calcification or twisting of blood vessels, artery narrowing or blockages above a certain level, artery aneurysms, a condition called fibromuscular dysplasia, or other significant artery abnormalities identified on imaging (confirm with trial site for full details)

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