Renal Denervation in Patients With Uncontrolled Blood Pressure
Recruitment status was: Recruiting
The kidneys are an important regulator of blood pressure. Previous research has shown that disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In the past, one technique that was used to treat severe high blood pressure was a surgical procedure to cut these nerves. However, this surgery is no longer commonly performed.
Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is currently approved in the United States to deliver ion dose therapy to re-narrowings that form in the coronary arteries in the heart. This trial is assessing the safety of treating patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney to help control blood pressure in patients with uncontrolled hypertension.
- Renal artery brachytherapy with beta-emitting source is safe.
- Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood pressure via renal denervation mechanism within 6 months post treatment.
|Blood Pressure||Radiation: Radiation Dose 25 Gy Radiation: Radiation Dose 50 Gy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION|
- Safety [ Time Frame: up to 6 months post procedure ]The primary safety endpoint for renal artery brachytherapy with beta-emitting source is any need for renal artery intervention to treat renal artery injury induced by the catheter of radiation within 6 months
- Efficacy [ Time Frame: up to 6 months post procedure ]The primary efficacy endpoint for renal artery brachytherapy with beta-emitting source is decrease in systolic and diastolic blood pressure of ≥10 mmHg at six months following the procedure.
- Angiographic [ Time Frame: up to 6 months post procedure ]The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)
- Effects on Blood Pressure [ Time Frame: up to 6 months post procedure ]Short term effects of renal artery brachytherapy on blood pressure
- Safety [ Time Frame: up to 24 months post procedure ]Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.
- eGFR or New Stenosis [ Time Frame: up to 6 months post procedure ]Estimated glomerular filtration rate (eGFR) drop >25% or new renal artery stenosis > 60% confirmed by angiogram at six months following renal artery brachytherapy procedure.
- Medication changes [ Time Frame: up to 24 months post procedure ]
Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically,
- Additions, changes and cessation of medications
- Dosage changes throughout the follow up duration
- Serious Adverse Events [ Time Frame: up to 24 months post procedure ]Rate of any serious adverse events or device-related adverse events
|Study Start Date:||August 2013|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Radiation dose 25 Gy
• 25 Gy: Subjects will be treated with beta radiation dosage of 25 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.
Radiation: Radiation Dose 25 Gy
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.
Active Comparator: Radiation dose 50 Gy
• 50 Gy: Subjects will be treated with beta radiation dosage of 50 Gy during renal denervation procedure. Subjects are to maintain baseline anti-hypertensive medications and will undergo follow-up for 24 months.
Radiation: Radiation Dose 50 Gy
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968785
|Contact: Ron Waksman, MDfirstname.lastname@example.org|
|United States, District of Columbia|
|MedStar Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Ron Waksman, MD 202-877-5975 email@example.com|
|Contact: Suman Singh 202-877-8475 firstname.lastname@example.org|
|Principal Investigator: Ron Waksman, MD|
|Principal Investigator:||Ron Waksman, MD||Medstar Washington Hospital Center|