Trials / Completed
CompletedNCT02444442
Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension
The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- Baker Heart and Diabetes Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure. A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm. The duration of this study is 36 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Renal Denervation | Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries. |
| OTHER | Sham control | Arterial access only. No delivery of radio frequency energy to renal arteries. |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2020-04-01
- Completion
- 2020-04-01
- First posted
- 2015-05-14
- Last updated
- 2023-09-14
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT02444442. Inclusion in this directory is not an endorsement.