Uncontrolled Hypertension
Conditions
Keywords
hypertension, renal denervation, sympathetic nervous system, RDN
Brief summary
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
Interventions
DEVICERenal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Office Systolic Blood Pressure Reduction | Baseline to 6 months | The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization. |
Countries
Australia, Austria, Belgium, France, Germany, Latvia, Poland, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
190 patients screened as eligible for study inclusion between June 9, 2009 and January 15, 2010.
Pre-assignment details
84 subjects excluded pre-randomization due to blood pressure value at baseline visit (n=36); ineligible anatomy (n=30); declined participation (n=10); and other exclusion criteria (n=8).
Participants by arm
| Arm | Count |
|---|---|
| Renal Denervation Renal Denervation and maintenance of anti-hypertensive medications | 52 |
| Control Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months | 54 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missed Visit | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Renal Denervation | Control |
|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 12 | 58.2 years STANDARD_DEVIATION 11.9 | 58.3 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment Australia | 10 participants | 5 participants | 5 participants |
| Region of Enrollment Austria | 3 participants | 1 participants | 2 participants |
| Region of Enrollment Belgium | 6 participants | 4 participants | 2 participants |
| Region of Enrollment France | 4 participants | 1 participants | 3 participants |
| Region of Enrollment Germany | 61 participants | 32 participants | 29 participants |
| Region of Enrollment Latvia | 7 participants | 3 participants | 4 participants |
| Region of Enrollment Poland | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Spain | 4 participants | 2 participants | 2 participants |
| Region of Enrollment Switzerland | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United Kingdom | 8 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 45 Participants | 18 Participants | 27 Participants |
| Sex: Female, Male Male | 61 Participants | 34 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 52 | 7 / 54 |
| serious Total, serious adverse events | 5 / 52 | 4 / 54 |
Outcome results
Primary
Office Systolic Blood Pressure Reduction
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Office Systolic Blood Pressure Reduction | -31.7 mmHg | Standard Deviation 23.1 |
| Control | Office Systolic Blood Pressure Reduction | 0.9 mmHg | Standard Deviation 20.6 |