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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01541865
First received: February 21, 2012
Last updated: October 23, 2015
Last verified: October 2015
Results First Received: September 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Device: Renal Denervation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Renal Denervation All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.

Participant Flow:   Overall Study
    Renal Denervation  
STARTED     146  
COMPLETED     124  
NOT COMPLETED     22  
Lost to Follow-up                 11  
Withdrawal by Subject                 9  
Adverse Event                 1  
Protocol Violation                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Renal Denervation All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.

Baseline Measures
    Renal Denervation  
Number of Participants  
[units: participants]
  146  
Age  
[units: years]
Mean (Standard Deviation)
  58.1  (10.4)  
Gender  
[units: participants]
 
Female     57  
Male     89  
Race/Ethnicity, Customized  
[units: participants]
 
White     135  
Black, Asian, Other     11  
Region of Enrollment  
[units: participants]
 
New Zealand     21  
Austria     13  
Netherlands     5  
Belgium     17  
Australia     31  
France     8  
Switzerland     2  
Germany     49  
Type 2 Diabetes  
[units: participants]
 
Type 2 Diabetes     41  
Non-Diabetic     105  
Coronary Artery Disease  
[units: participants]
 
Coronary Artery Disease     55  
No Coronary Artery Disease     91  
Congestive Heart Failure  
[units: participants]
 
Congestive Heart Failure     3  
No Congestive Heart Failure     143  
Dyslipidemia  
[units: participants]
 
Dyslipidemia     85  
No Dyslipidemia     61  
Baseline Systolic Blood Pressure  
[units: mm Hg]
Mean (Standard Deviation)
  182.4  (18.4)  
Baseline Diastolic Blood Pressure  
[units: mm Hg]
Mean (Standard Deviation)
  100.2  (14.0)  
Heart Rate  
[units: beats/min]
Mean (Standard Deviation)
  71.7  (14.8)  
Estimated glomerular filtration rate (eGFR)  
[units: mL/min/1.73m^2]
Mean (Standard Deviation)
  82.7  (22.5)  
Serum Creatinine  
[units: micromol/L]
Mean (Standard Deviation)
  82.0  (20.0)  
Number of Antihypertensive Medications per Patient  
[units: Antihypertensive Medications per Patient]
Mean (Standard Deviation)
  4.8  (1.5)  
Antihypertensive Medications  
[units: 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  



  Outcome Measures
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1.  Primary:   Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment   [ Time Frame: Baseline and 6 months ]

2.  Primary:   Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Absence of Flow Limiting Stenosis in the Renal Artery   [ Time Frame: 6 months ]

4.  Secondary:   Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery   [ Time Frame: Duration of the procedure (average of 65 minutes) ]

5.  Secondary:   Renal Artery Infarction or Embolus   [ Time Frame: Duration of the procedure (average of 65 minutes) ]

6.  Secondary:   Cerebrovascular Accident (CVA) at Time of Procedure   [ Time Frame: Duration of the procedure (average of 65 minutes) ]

7.  Secondary:   Myocardial Infarction at Time of Procedure   [ Time Frame: Duration of the procedure (average of 65 minutes) ]

8.  Secondary:   Sudden Cardiac Death at Time of Procedure   [ Time Frame: Duration of the procedure (average of 65 minutes) ]

9.  Secondary:   Angiographically-documented Renal Stenosis Requiring an Intervention   [ Time Frame: 2 Years ]

10.  Secondary:   Chronic Symptomatic Orthostatic Hypotension   [ Time Frame: 2 Years ]

11.  Secondary:   Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)   [ Time Frame: 2 Years ]

12.  Secondary:   Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%   [ Time Frame: 2 Years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Angela Schutt, Clinical Trial Manager
Organization: Boston Scientific
phone: 763-494-2166
e-mail: angela.schutt@bsci.com


Publications of Results:

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01541865     History of Changes
Other Study ID Numbers: CR002-020
Study First Received: February 21, 2012
Results First Received: September 15, 2015
Last Updated: October 23, 2015
Health Authority: Austria: BASG/AGES PharmMed