N/A
N=106
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Uncontrolled Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00888433 ↗Enrolled (actual)
106
Serious AEs
8.5%
Results posted
Feb 2014
Primary outcome: Primary: Office Systolic Blood Pressure Reduction — -31.7; 0.9 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Renal Denervation (Symplicity® Renal Denervation System) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Office Systolic Blood Pressure Reduction |
-31.7; 0.9 | — |
Summary
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
Eligibility Criteria
Inclusion Criteria
- systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
- on 3 or more antihypertensive medications
- >= 18 and =< 85 years of age.
Exclusion Criteria
- renal artery abnormalities
- eGFR < 45mL/min
- MI, angina, CVA within 6 months
- Type 1 diabetes
- ICD or pacemaker, or any other metallic implant not compatible with MRI
- others
Data sourced from ClinicalTrials.gov (NCT00888433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.