Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients (NCT01438229) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Australia, Greece47 participantsStarted 2011-10
Plain-language summary
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
* Age ≥18 and ≤80 years old
* Able and willing to provide written informed consent to participate in the study
* Able and willing to comply with the required follow-up schedule
Exclusion Criteria:
* Prior renal artery intervention (balloon angioplasty or stenting)
* Evidence of renal artery atherosclerosis (defined as a stenotic severity of \>30%) in either renal artery
* Multiple main renal arteries in either kidney
* Main renal arteries \<4 mm in diameter or \<20 mm in length
* eGFR of \<45 mL/min per 1.73 m2 using the MDRD formula
* Type 1 diabetes
* Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
* Others