EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension (EnligHTN-IV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01903187
First received: July 9, 2013
Last updated: March 15, 2016
Last verified: March 2016
Results First Received: October 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Device: EnligHTN Renal Denervation
Procedure: Sham

  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
No text entered.

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

Renal artery ablation with the EnligHTN™ Renal Denervation System.

EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system

Sham Procedure

Sham procedure

Sham: Renal artery angiogram


Participant Flow for 5 periods

Period 1:   Procedure
    Renal Denervation     Sham Procedure  
STARTED     2     2  
COMPLETED     2     2  
NOT COMPLETED     0     0  

Period 2:   1 Month
    Renal Denervation     Sham Procedure  
STARTED     2     2  
COMPLETED     2     2  
NOT COMPLETED     0     0  

Period 3:   3 Month
    Renal Denervation     Sham Procedure  
STARTED     2     0  
COMPLETED     2     0  
NOT COMPLETED     0     0  

Period 4:   6 Month
    Renal Denervation     Sham Procedure  
STARTED     2     0  
COMPLETED     2     0  
NOT COMPLETED     0     0  

Period 5:   12 Month
    Renal Denervation     Sham Procedure  
STARTED     2     0  
COMPLETED     2     0  
NOT COMPLETED     0     0  



  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.
All subjects enrolled.

Reporting Groups
  Description
Renal Denervation

Renal artery ablation with the EnligHTN™ Renal Denervation System.

EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system

Sham Procedure

Sham procedure

Sham: Renal artery angiogram

Total Total of all reporting groups

Baseline Measures
    Renal Denervation     Sham Procedure     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: years]
Mean (Standard Deviation)
  54.1  (8.9)     60.4  (6.7)     57.2  (7.4)  
Gender  
[units: participants]
     
Female     2     1     3  
Male     0     1     1  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     2     2     4  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     1     2     3  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Height  
[units: centimeters]
Mean (Standard Deviation)
  172.9  (14.1)     171.5  (5.4)     172.2  (8.7)  
Weight  
[units: kilograms]
Mean (Standard Deviation)
  81.0  (18.4)     108.0  (25.0)     94.5  (23.7)  
BMI [1]
[units: kg/m^2]
Mean (Standard Deviation)
  27.9  (10.6)     36.5  (6.2)     32.2  (8.7)  
Years with hypertension  
[units: years]
Mean (Standard Deviation)
  30.5  (0.7)     36.0  (0)     32.3  (3.2)  
Coronary Artery Disease  
[units: participants]
     
Yes     1     0     1  
No     1     2     3  
Renal Artery Stenosis  
[units: participants]
     
Yes     0     0     0  
No     2     2     4  
Hyperlipidemia  
[units: participants]
     
Yes     1     2     3  
No     1     0     1  
Type II Diabetes  
[units: participants]
     
Yes     0     0     0  
No     2     2     4  
Obstructive Sleep Apnea  
[units: participants]
     
Yes     0     1     1  
No     2     1     3  
eGFR [2]
[units: mL/min/1.73 m2]
Mean (Standard Deviation)
  91.0  (26.9)     71.5  (14.8)     81.3  (21.0)  
Serum Creatinine  
[units: umol/L]
Mean (Standard Deviation)
  69.0  (26.9)     83.0  (1.4)     76.0  (17.5)  
Cystatin C  
[units: mg/L]
Mean (Standard Deviation)
  0.76  (0.25)     0.98  (0.18)     0.87  (0.22)  
Urine Albumin to Creatinine Ratio [3]
[units: mg/g]
Mean (Standard Deviation)
  10.5  (2.1)     98.0  (106.1)     54.3  (79.4)  
Office Systolic BP  
[units: mmHg]
Mean (Standard Deviation)
  178.0  (17.0)     199.5  (34.6)     188.8  (25.5)  
Office Diastolic BP  
[units: mmHg]
Mean (Standard Deviation)
  111.5  (4.9)     88.0  (1.4)     99.8  (13.9)  
Office Heart Rate  
[units: beats/minute]
Mean (Standard Deviation)
  76.5  (12.0)     58.5  (7.8)     67.5  (13.3)  
24-Hr Ambulatory Systolic BP  
[units: mmHg]
Mean (Standard Deviation)
  151.7  (22.9)     155.3  (4.3)     153.5  (13.6)  
24-Hr Ambulatory Diastolic BP  
[units: mmHg]
Mean (Standard Deviation)
  92.5  (24.7)     75.4  (1.4)     83.9  (17.4)  
24-Hr Ambulatory Heart Rate  
[units: beats/minute]
Mean (Standard Deviation)
  68.2  (2.9)     60.5  (16.0)     64.3  (10.4)  
Daytime Ambulatory Systolic BP  
[units: mmHg]
Mean (Standard Deviation)
  161.4  (27.0)     155.0  (2.7)     158.2  (16.1)  
Daytime Ambulatory Diastolic BP  
[units: mmHg]
Mean (Standard Deviation)
  99.8  (27.6)     75.6  (1.8)     87.7  (21.2)  
Daytime Ambulatory Heart Rate  
[units: beats/minute]
Mean (Standard Deviation)
  69.4  (1.6)     60.6  (18.3)     65.0  (11.7)  
Number of Anti-hypertensive medications  
[units: number of anti-hypertensive medications]
Mean (Standard Deviation)
  4.0  (1.4)     5.5  (0.7)     4.8  (1.3)  
[1] Body mass index
[2]

Estimated glomular filtration rate use Modified Diet in Renal Disease formula:

For creatinine in µmol/L:

eGFR = 32788 X Serum Creatinine^-1.154 X Age^-0.203 X [1.210 if Black] X [0.742 if Female]

[3] Ratio reported as milligrams of albumin per gram of creatinine.



  Outcome Measures
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1.  Primary:   The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).   [ Time Frame: 6 months post randomization ]

2.  Primary:   The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups   [ Time Frame: 6 months post randomization ]

3.  Secondary:   Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months   [ Time Frame: 6 months post randomization ]

4.  Secondary:   The Number of Subjects That Experience Each Type of MAE   [ Time Frame: 6 months post randomization ]

5.  Secondary:   Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP   [ Time Frame: 6 months post randomization, and all follow-up timepoints ]

6.  Secondary:   Reduction in Ambulatory Blood Pressure (ABP) Parameters   [ Time Frame: baseline, 6 months post randomization, and all follow-up timepoints ]


  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
Enrollment ended early due to a sponsor decision unrelated to safety. The 2 treatment group subjects are being followed up through 3 years. The 2 sham group subjects were exited after their 1 month visit. Due to these reasons, data is limited.


  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: Steven Madej
Organization: St. Jude Medical, Inc.
phone: 651-756-2230
e-mail: smadej@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01903187     History of Changes
Other Study ID Numbers: 1204
Study First Received: July 9, 2013
Results First Received: October 15, 2015
Last Updated: March 15, 2016
Health Authority: United States: Food and Drug Administration