Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Primary endpoint
Study Overview
Brief Summary
Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed arterial hypertension with systolic or diastolic blood pressure >140/90 mmHg in standardized office blood pressure measurement
- •Treatment with 3 to ≤5 antihypertensive drug classes
- •Age >18 years
- •Written informed consent
Exclusion Criteria
- •Age ≤ 18 years
- •anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
- •patients under legal supervision or guardianship
- •participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.
Arms & Interventions
Renal sympathetic denervation
All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist.
Intervention: Renal sympathetic denervation (Procedure)
Outcomes
Primary Outcomes
Primary endpoint
Time Frame: target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Difference in time in blood pressure target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Secondary Outcomes
- Secondary endpoints(up to 12 months)
- Secondary endpoints(months 7 to 9)
- Secondary endpoints(one week before renal denervation vs. 6 months after renal denervation)