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Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN)

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: NCT01541865
Recruitment Status : Completed
First Posted : March 1, 2012
Results First Posted : October 16, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Device: Renal Denervation
Enrollment 146
Recruitment Details Enrollment of up to 150 subjects was planned; 146 subjects were enrolled at 23 centers in the Europe, Australia and New Zealand from February 22, 2012 to April 8, 2013.
Pre-assignment Details  
Arm/Group Title Renal Denervation
Hide Arm/Group Description All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Period Title: Overall Study
Started 146
Completed 124
Not Completed 22
Reason Not Completed
Lost to Follow-up             11
Withdrawal by Subject             9
Adverse Event             1
Protocol Violation             1
Arm/Group Title Renal Denervation
Hide Arm/Group Description All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Baseline Participants 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants
58.1  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Female
57
  39.0%
Male
89
  61.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
White 135
Black, Asian, Other 11
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
New Zealand 21
Austria 13
Netherlands 5
Belgium 17
Australia 31
France 8
Switzerland 2
Germany 49
Type 2 Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
Type 2 Diabetes 41
Non-Diabetic 105
Coronary Artery Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
Coronary Artery Disease 55
No Coronary Artery Disease 91
Congestive Heart Failure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
Congestive Heart Failure 3
No Congestive Heart Failure 143
Dyslipidemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
Dyslipidemia 85
No Dyslipidemia 61
Baseline Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 146 participants
182.4  (18.4)
Baseline Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 146 participants
100.2  (14.0)
Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats/min
Number Analyzed 146 participants
71.7  (14.8)
Estimated glomerular filtration rate (eGFR)  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73m^2
Number Analyzed 146 participants
82.7  (22.5)
Serum Creatinine  
Mean (Standard Deviation)
Unit of measure:  micromol/L
Number Analyzed 146 participants
82.0  (20.0)
Number of Antihypertensive Medications per Patient  
Mean (Standard Deviation)
Unit of measure:  Antihypertensive Medications per Patient
Number Analyzed 146 participants
4.8  (1.5)
Antihypertensive Medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
Subjects on greater than or equal to 5 medications 79
Subjects on 4 medications 38
Subjects on 3 medications 26
Subjects on 2 medications 3
1.Primary Outcome
Title Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment
Hide Description Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic -24.5  (22.1)
Diastolic -10.3  (12.7)
2.Primary Outcome
Title Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure
Hide Description Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment.
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic -8.0  (14.6)
Diastolic -5.7  (9.2)
3.Secondary Outcome
Title Absence of Flow Limiting Stenosis in the Renal Artery
Hide Description Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 143
Measure Type: Number
Unit of Measure: participants w/o flow limiting stenosis
139
4.Secondary Outcome
Title Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery
Hide Description [Not Specified]
Time Frame Duration of the procedure (average of 65 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
0
5.Secondary Outcome
Title Renal Artery Infarction or Embolus
Hide Description [Not Specified]
Time Frame Duration of the procedure (average of 65 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Cerebrovascular Accident (CVA) at Time of Procedure
Hide Description [Not Specified]
Time Frame Duration of the procedure (average of 65 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
0
7.Secondary Outcome
Title Myocardial Infarction at Time of Procedure
Hide Description [Not Specified]
Time Frame Duration of the procedure (average of 65 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
0
8.Secondary Outcome
Title Sudden Cardiac Death at Time of Procedure
Hide Description [Not Specified]
Time Frame Duration of the procedure (average of 65 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
0
9.Secondary Outcome
Title Angiographically-documented Renal Stenosis Requiring an Intervention
Hide Description [Not Specified]
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: participants
1
10.Secondary Outcome
Title Chronic Symptomatic Orthostatic Hypotension
Hide Description [Not Specified]
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: participants
0
11.Secondary Outcome
Title Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)
Hide Description [Not Specified]
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: participants
10
12.Secondary Outcome
Title Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%
Hide Description [Not Specified]
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.
Arm/Group Title Renal Denervation
Hide Arm/Group Description:
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: participants
16
Time Frame Adverse events were collect through the 2 year follow up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Renal Denervation
Hide Arm/Group Description All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
All-Cause Mortality
Renal Denervation
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Renal Denervation
Affected / at Risk (%) # Events
Total   69/146 (47.26%)    
Cardiac disorders   
Myocardial Infarction  4/146 (2.74%)  6
Congestive Heart Failure  5/146 (3.42%)  8
Other Cardiac - Chest Pain/Angina  7/146 (4.79%)  8
Other Cardiac - Fibrillation  5/146 (3.42%)  5
Other Cardiac - Tachycardia  1/146 (0.68%)  1
Gastrointestinal disorders   
Other - Gastrointestinal/Rectal  6/146 (4.11%)  7
General disorders   
Other Neurological  2/146 (1.37%)  2
Other - Thoracic/Abdominal Pain  4/146 (2.74%)  4
Other - Hernia  1/146 (0.68%)  1
Other - Deconditioning post medical illness  1/146 (0.68%)  1
Other - Dementia  1/146 (0.68%)  1
Other - Nausea  1/146 (0.68%)  1
Other - Overdose  1/146 (0.68%)  1
Infections and infestations   
Other Infectious/Inflammatory  9/146 (6.16%)  10
Other - Inflammation/Infection  10/146 (6.85%)  14
Metabolism and nutrition disorders   
Other - Diabetes  5/146 (3.42%)  6
Musculoskeletal and connective tissue disorders   
Other - Skeletal/Connective Tissue  13/146 (8.90%)  19
Psychiatric disorders   
Other - Suicide Ideation  1/146 (0.68%)  1
Renal and urinary disorders   
Renal Insufficiency  1/146 (0.68%)  1
Renal Failure  3/146 (2.05%)  3
Other - Hypertension  13/146 (8.90%)  21
Reproductive system and breast disorders   
Unanticipated Adverse Events - Prolapsis Uteri  1/146 (0.68%)  1
Other - Priapismus  1/146 (0.68%)  1
Other - Prostate Carcinoma  1/146 (0.68%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1/146 (0.68%)  1
Other Pulmonary  7/146 (4.79%)  7
Other - Sleep Apnoea  1/146 (0.68%)  1
Surgical and medical procedures   
Access Site Infection [1]  2/146 (1.37%)  2
Clot or Thrombus Formation [1]  1/146 (0.68%)  1
Hematoma [1]  1/146 (0.68%)  1
Other Vascular - Stenosis [2]  1/146 (0.68%)  1
Pseudoaneurysm [1]  1/146 (0.68%)  1
Other - Flank Pain [1]  1/146 (0.68%)  1
Other - Digestive (vomiting) [1]  1/146 (0.68%)  1
Other - Hypertensive Crisis [2]  4/146 (2.74%)  5
Other Cardiac - Hypertensive episode [3]  1/146 (0.68%)  2
Acute Occlusion/Vessel Closure  1/146 (0.68%)  1
Stent Required  1/146 (0.68%)  1
Other - Elective Surgery  2/146 (1.37%)  2
Vascular disorders   
Other Vascular - Carotid Stenosis  1/146 (0.68%)  1
Other Renal - Renal Calcification  1/146 (0.68%)  1
Stroke  2/146 (1.37%)  2
Other - Limb oedema/ Ulceration  2/146 (1.37%)  2
Other - Coronary Sub-Occlusion  1/146 (0.68%)  1
[1]
Procedure Related
[2]
Device Related/Procedure Related
[3]
Device Related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Renal Denervation
Affected / at Risk (%) # Events
Total   70/146 (47.95%)    
General disorders   
Pain [1]  23/146 (15.75%)  23
Anaesthesia Related - Nausea/Vomiting [1]  12/146 (8.22%)  14
Dizziness [2]  16/146 (10.96%)  18
Hypertension [2]  14/146 (9.59%)  14
Renal and urinary disorders   
Reduced Kidney Function [3]  9/146 (6.16%)  9
Skin and subcutaneous tissue disorders   
Access Site Complications [1]  20/146 (13.70%)  22
Hematoma [1]  18/146 (12.33%)  19
[1]
Procedure Related
[2]
Potentially Related to Device and/or Procedure
[3]
Device Related
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: Angela Schutt, Clinical Trial Manager
Organization: Boston Scientific
Phone: 763-494-2166
EMail: angela.schutt@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01541865    
Other Study ID Numbers: CR002-020
First Submitted: February 21, 2012
First Posted: March 1, 2012
Results First Submitted: September 15, 2015
Results First Posted: October 16, 2015
Last Update Posted: November 25, 2015