Renal Denervation in Patients With Refractory Hypertension
Phase 1
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00483808
- Lead Sponsor
- Medtronic Vascular
- Brief Summary
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
- >= 18 years of age.
- a systolic blood pressure of 160 mmHg or greater.
- receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
- agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
- competent and willing to provide written, informed consent to participate in this clinical study.
Exclusion Criteria
- renal arterial abnormalities
- end stage renal disease requiring dialysis or renal transplant
- serum Cr > 3, or calculated GFR < 45 ml/min
- has experienced MI, unstable angina pectoris, or CVA with 6 months
- others
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To provide confirmation that renal denervation is safe and feasible. 3 years
- Secondary Outcome Measures
Name Time Method Evidence of renal denervation; indication of physiologic response; assessment of device performance. 3 years
Trial Locations
- Locations (3)
St. Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
John Paul II Hospital
🇵🇱Krakow, Poland
St. Vincent's Hospital🇦🇺Fitzroy, Victoria, Australia