Trial Outcomes & Findings for Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) (NCT NCT00888433)
NCT ID: NCT00888433
Last Updated: 2015-05-20
Results Overview
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2015-05-20
Participant Flow
190 patients screened as eligible for study inclusion between June 9, 2009 and January 15, 2010.
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).
Participant milestones
| Measure |
Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications
|
Control
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications
|
Control
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Missed Visit
|
2
|
1
|
Baseline Characteristics
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Baseline characteristics by cohort
| Measure |
Renal Denervation
n=52 Participants
Renal Denervation and maintenance of anti-hypertensive medications
|
Control
n=54 Participants
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 11.9 • n=93 Participants
|
58.3 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
58.2 years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Latvia
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
32 participants
n=93 Participants
|
29 participants
n=4 Participants
|
61 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsThe primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
Outcome measures
| Measure |
Renal Denervation
n=49 Participants
Renal Denervation and maintenance of anti-hypertensive medications
|
Control
n=51 Participants
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
|
|---|---|---|
|
Office Systolic Blood Pressure Reduction
|
-31.7 mmHg
Standard Deviation 23.1
|
0.9 mmHg
Standard Deviation 20.6
|
Adverse Events
1. DENERVATION
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
2. CONTROL
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. DENERVATION
n=52 participants at risk
Renal Denervation and maintenance of anti-hypertensive medications
|
2. CONTROL
n=54 participants at risk
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/52 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
|
General disorders
Asthenia
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
|
General disorders
Oedema
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52 • Number of events 2 • 12 months
|
0.00%
0/54 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/52 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dysarthria
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
|
Surgical and medical procedures
Intra-Cerebral Aneurysm Operation
|
0.00%
0/52 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 2 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypertensive Crisis
|
3.8%
2/52 • Number of events 2 • 12 months
|
0.00%
0/54 • 12 months
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
Other adverse events
| Measure |
1. DENERVATION
n=52 participants at risk
Renal Denervation and maintenance of anti-hypertensive medications
|
2. CONTROL
n=54 participants at risk
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
5.8%
3/52 • Number of events 3 • 12 months
|
0.00%
0/54 • 12 months
|
|
General disorders
Oedema Peripheral
|
5.8%
3/52 • Number of events 6 • 12 months
|
0.00%
0/54 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.6%
5/52 • Number of events 13 • 12 months
|
0.00%
0/54 • 12 months
|
|
Nervous system disorders
Dizziness
|
7.7%
4/52 • Number of events 6 • 12 months
|
0.00%
0/54 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/52 • 12 months
|
5.6%
3/54 • Number of events 7 • 12 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/52 • 12 months
|
7.4%
4/54 • Number of events 7 • 12 months
|
|
Vascular disorders
Hypotension
|
5.8%
3/52 • Number of events 5 • 12 months
|
0.00%
0/54 • 12 months
|
Additional Information
Murray Esler, Principal Investigator
Baker IDI Heart and Diabetes Institute
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The institution agrees that no Publication of the Study Results may be made until Publication of the results of the multi-centre study or 2 years after Study Completion, whichever is sooner.
- Publication restrictions are in place
Restriction type: OTHER