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Impact of Renal SympAthetic DenerVation on Chronic HypErtension (SAVE)

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: NCT01628198
Recruitment Status : Terminated (recommendation by the study's DSMB due to insufficient data to determine efficacy.)
First Posted : June 26, 2012
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Uncontrolled Hypertension
Intervention: Device: Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter

  Participant Flow

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 Group Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.

Participant Flow:   Overall Study
    Renal Denervation Group
STARTED   38 
COMPLETED   20 
NOT COMPLETED   18 
Lost to Follow-up                7 
Withdrawal by Subject                10 
Screen failure                1 



  Baseline Characteristics

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 Group Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.

Baseline Measures
   Renal Denervation Group 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.3  (11.65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18  47.4% 
Male      20  52.6% 


  Outcome Measures

1.  Primary:   Mean Change in Ambulatory Systolic Blood Pressure   [ Time Frame: baseline and 6 months ]

2.  Primary:   Change in Ambulatory Diastolic Blood Pressure   [ Time Frame: baseline and 6 months ]

3.  Secondary:   Office Systolic BP   [ Time Frame: baseline, 6 month, 12 months ]

4.  Secondary:   Office Diastolic BP   [ Time Frame: baseline, 6 month, 12 months ]

5.  Secondary:   Renal Aortic Ratio   [ Time Frame: Baseline and 12 months ]

6.  Secondary:   Resistive Index   [ Time Frame: Baseline and 12 months ]

7.  Secondary:   Renal Artery Dimensions   [ Time Frame: baseline and 12 months ]

8.  Secondary:   Blood Urea Nitrogen   [ Time Frame: baseline, 6 months, 12 months ]

9.  Secondary:   Creatinine   [ Time Frame: baseline, 6 months, 12 months ]

10.  Secondary:   Anti-hypertensive Medications   [ Time Frame: Baseline, 6 months, 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Vivek Y Reddy
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-7114
e-mail: vivek.reddy@mountsinai.org


Publications:


Responsible Party: Vivek Reddy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01628198     History of Changes
Other Study ID Numbers: GCO 12-0740
First Submitted: June 12, 2012
First Posted: June 26, 2012
Results First Submitted: April 17, 2017
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018