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Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) (HTN-2)

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ClinicalTrials.gov Identifier: NCT00888433
Recruitment Status : Completed
First Posted : April 27, 2009
Results First Posted : February 24, 2014
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Uncontrolled Hypertension
Intervention Device: Renal Denervation (Symplicity® Renal Denervation System)
Enrollment 106

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).
Arm/Group Title Renal Denervation Control
Hide Arm/Group Description Renal Denervation and maintenance of anti-hypertensive medications Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
Period Title: Overall Study
Started 52 54
Completed 49 51
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             1             2
Missed Visit             2             1
Arm/Group Title Renal Denervation Control Total
Hide Arm/Group Description Renal Denervation and maintenance of anti-hypertensive medications Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months Total of all reporting groups
Overall Number of Baseline Participants 52 54 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 54 participants 106 participants
58.2  (11.9) 58.3  (12.3) 58.2  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 54 participants 106 participants
Female
18
  34.6%
27
  50.0%
45
  42.5%
Male
34
  65.4%
27
  50.0%
61
  57.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 54 participants 106 participants
France 1 3 4
Poland 1 1 2
Belgium 4 2 6
Spain 2 2 4
Australia 5 5 10
Austria 1 2 3
Latvia 3 4 7
Germany 32 29 61
Switzerland 0 1 1
United Kingdom 3 5 8
1.Primary Outcome
Title Office Systolic Blood Pressure Reduction
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Control
Hide Arm/Group Description:
Renal Denervation and maintenance of anti-hypertensive medications
Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: mmHg
-31.7  (23.1) 0.9  (20.6)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1. DENERVATION 2. CONTROL
Hide Arm/Group Description Renal Denervation and maintenance of anti-hypertensive medications Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
All-Cause Mortality
1. DENERVATION 2. CONTROL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1. DENERVATION 2. CONTROL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/52 (9.62%)      4/54 (7.41%)    
Cardiac disorders     
Atrial Fibrillation  1  0/52 (0.00%)  0 1/54 (1.85%)  1
Ear and labyrinth disorders     
Vertigo  1  1/52 (1.92%)  1 0/54 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  1/52 (1.92%)  1 0/54 (0.00%)  0
Vomiting  1  1/52 (1.92%)  1 0/54 (0.00%)  0
General disorders     
Asthenia  1  1/52 (1.92%)  1 0/54 (0.00%)  0
Oedema  1  1/52 (1.92%)  1 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/52 (1.92%)  2 0/54 (0.00%)  0
Nervous system disorders     
Cerebrovascular Accident  1  0/52 (0.00%)  0 1/54 (1.85%)  1
Dysarthria  1  1/52 (1.92%)  1 0/54 (0.00%)  0
Surgical and medical procedures     
Intra-Cerebral Aneurysm Operation  1  0/52 (0.00%)  0 1/54 (1.85%)  1
Vascular disorders     
Hypertension  1  1/52 (1.92%)  2 1/54 (1.85%)  1
Hypertensive Crisis  1  2/52 (3.85%)  2 0/54 (0.00%)  0
Hypotension  1  1/52 (1.92%)  1 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1. DENERVATION 2. CONTROL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/52 (34.62%)      7/54 (12.96%)    
Cardiac disorders     
Bradycardia  1  3/52 (5.77%)  3 0/54 (0.00%)  0
General disorders     
Oedema Peripheral  1  3/52 (5.77%)  6 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1  5/52 (9.62%)  13 0/54 (0.00%)  0
Nervous system disorders     
Dizziness  1  4/52 (7.69%)  6 0/54 (0.00%)  0
Headache  1  0/52 (0.00%)  0 3/54 (5.56%)  7
Vascular disorders     
Hypertensive Crisis  1  0/52 (0.00%)  0 4/54 (7.41%)  7
Hypotension  1  3/52 (5.77%)  5 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Murray Esler, Principal Investigator
Organization: Baker IDI Heart and Diabetes Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00888433     History of Changes
Other Study ID Numbers: TP-058
First Submitted: April 24, 2009
First Posted: April 27, 2009
Results First Submitted: September 13, 2013
Results First Posted: February 24, 2014
Last Update Posted: May 20, 2015