NCT01968785

Renal Denervation in Patients With Uncontrolled Blood Pressure

RENAL ARTERY IRRADIATION FOR SYMPATHETIC RENAL DENERVATION IN PATIENTS WITH RESISTANT HYPERTENSION

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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. 1. Renal artery brachytherapy with beta-emitting source is safe. 2. Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood pressure via renal denervation mechanism within 6 months post treatment.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-10-24
• Last updated: 2022-01-13
• Results posted: 2022-01-13

Locations

1 site across 1 country: United States