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Study of Renal Denervation in Patients With Heart Failure (PRESERVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954160
Recruitment Status : Terminated (DSMB decision based upon noted lack of efficacy in manufacturers pivotal trials.)
First Posted : October 1, 2013
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Medtronic
Information provided by (Responsible Party):
Adrian Hernandez, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure
Intervention Device: Symplicity Renal Denervation
Enrollment 5
Recruitment Details  
Pre-assignment Details 5 participants were enrolled. 4 subjects received treatment, 1 subject did not receive treatment due to ineligibility secondary to renal doppler findings.
Arm/Group Title Early Renal Denervation Late Renal Denervation
Hide Arm/Group Description

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

Period Title: Overall Study
Started 5 0 [1]
Completed 0 [2] 0
Not Completed 5 0
[1]
Not started
[2]
Only 4 subjects completed the first early denervation. No subjects completed the late denervation.
Arm/Group Title Early Renal Denervation Late Renal Denervation Total
Hide Arm/Group Description

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

Total of all reporting groups
Overall Number of Baseline Participants 4 0 4
Hide Baseline Analysis Population Description
All patients were required to have suitable anatomy per renal ultrasound. One randomized subject did not have suitable anatomy to proceed to renal denervaton.
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
<=18 years 0 0
Between 18 and 65 years 4 4
>=65 years 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 0 participants 4 participants
52.5  (4.4) 52.5  (4.4)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
Female 1 1
Male 3 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 0 participants 4 participants
4 4
1.Primary Outcome
Title Urine Sodium Excretion
Hide Description Within-subject comparison of increase in urine sodium excretion following saline loading before RSD and 13 weeks following RSD.
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected, endpoints not measured
Arm/Group Title Early Renal Denervation Late Renal Denervation
Hide Arm/Group Description:

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Urine Volume
Hide Description Urine volume following furosemide therapy after sodium loading.
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 24-hour Urine Sodium Excretion
Hide Description Difference in 24-hour urine sodium excretion, compared between pre-RSD and 13 weeks after RSD.
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Glomerular Filtration Rate
Hide Description Estimated Glomerular Filtration Rate (GFR) by creatinine and cystatin C
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Serum Cystatin C
Hide Description Study terminated early, endpoints not measured
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Blood Urea Nitrogen (BUN) Level
Hide Description Study terminated early, endpoints not measured
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Creatinine Clearance From 24-hour Urine Creatinine
Hide Description Study terminated early, endpoints not measured
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Urine Albumin
Hide Description Urine albumin
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Renal Resistive Index
Hide Description Intra-renal hemodynamics as measured by Renal Resistive Index (RRI) by renal Doppler ultrasonography Study terminated early, endpoints not measured
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Left Ventricular End Systolic Volume
Hide Description Echo: Left ventricular end systolic volume Study terminated early, endpoints not measured
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Left Ventricular Ejection Fraction
Hide Description Echo: Left Ventricular Ejection Fraction Study terminated early, endpoints not measured
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Global Longitudinal Strain
Hide Description Echo: Global longitudinal strain Study terminated early, endpoints not measured
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title LV End Systolic Dimension (LVESd)
Hide Description Echo: LV end systolic dimension (LVESd)
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title LV End Diastolic Dimension (LVEDd)
Hide Description Echo: LV end diastolic dimension (LVEDd)
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Left Atrial Size
Hide Description Echo: Left Atrial size
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Plasma N-terminal Pro-brain Natriuretic Peptide
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Resting Plasma Norepinephrine
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Resting Urine Norepinephrine
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Plasma Renin Activity
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Plasma Aldosterone
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title 6 Minute Walk Test
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Kansas City Cardiomyopathy Questionnaire Score
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Patient Global Assessment
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Symplisity Renal Denervation Late Symplisity Renal Denervation
Hide Arm/Group Description:

Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit

Symplicity Renal Denervation: Renal denervation

Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation: Renal denervation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title New York Heart Association (NYHA) Functional Classification
Hide Description [Not Specified]
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Renal Denervation Late Renal Denervation
Hide Arm/Group Description:

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Heart Rate Variability
Hide Description Heart rate variability indices by Holter
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Renal Denervation Late Renal Denervation
Hide Arm/Group Description:

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Tissue Doppler Indices
Hide Description Echo: Tissue Doppler indices
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Renal Denervation Late Renal Denervation
Hide Arm/Group Description:

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Left Ventricular End Diastolic Volume
Hide Description Echo: Left Ventricular End Diastolic Volume
Time Frame 13 Weeks following Renal Denervation
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data not collected and therefore endpoints were not measured.
Arm/Group Title Early Renal Denervation Late Renal Denervation
Hide Arm/Group Description:

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to one year post randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Renal Denervation Late Renal Denervation
Hide Arm/Group Description

Subjects undergo renal denervation within 2 weeks of baseline visit

Symplicity Renal Denervation System

Subjects undergo renal denervation within 2 weeks of Week 13 visit

Symplicity Renal Denervation System

All-Cause Mortality
Early Renal Denervation Late Renal Denervation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Early Renal Denervation Late Renal Denervation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/0    
Cardiac disorders     
Cardiomyopathy  1  1/4 (25.00%)  1 0/0  0
Metabolism and nutrition disorders     
Hyperglycemia  1  1/4 (25.00%)  1 0/0  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%
Early Renal Denervation Late Renal Denervation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/0    
General disorders     
Non Cardiac Chest Pain  1  1/4 (25.00%)  1 0/0  0
Musculoskeletal and connective tissue disorders     
Groin Pain  1  1/4 (25.00%)  1 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Data Safety Monitoring Board (DSMB) terminated trial based upon noted lack of efficacy in manufacturers pivotal trials. Endpoint data not collected or analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathy Moore
Organization: Duke Clinical Research Institute
Phone: 919-668-8065
EMail: kathy.moore@dm.duke.edu
Layout table for additonal information
Responsible Party: Adrian Hernandez, Duke University
ClinicalTrials.gov Identifier: NCT01954160     History of Changes
Other Study ID Numbers: Pro00047050
5U10HL084904 ( U.S. NIH Grant/Contract )
First Submitted: September 24, 2013
First Posted: October 1, 2013
Results First Submitted: December 30, 2015
Results First Posted: February 2, 2016
Last Update Posted: February 2, 2016