Strategies for Aggressive Central Afterload Reduction in Patients With Heart Failure (SACAR)

This study has been completed.
Sponsor:
Collaborator:
AtCor Medical, Inc.
Information provided by (Responsible Party):
Barry Borlaug, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588692
First received: December 21, 2007
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: January 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Device: SphygmoCor

  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
SphygmoCor Unblinded

The use of the sphygmocor values will determine medication adjustments to optimize heart failure (HF) treatment.

SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure.

SphygmoCor Blinded

Sphygmocor values will be blinded to the investigator.

SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure.


Participant Flow:   Overall Study
    SphygmoCor Unblinded     SphygmoCor Blinded  
STARTED     30     30  
COMPLETED     23     27  
NOT COMPLETED     7     3  
Withdrawal by Subject                 4                 2  
Hip Surgery                 0                 1  
Severe Peptic Ulcer Disease                 1                 0  
Cancer                 1                 0  
Death                 1                 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.
Only the participants who completed the trial were included in the baseline analysis.

Reporting Groups
  Description
SphygmoCor Unblinded The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
SphygmoCor Blinded Sphygmocor values will be blinded to the investigator.
Total Total of all reporting groups

Baseline Measures
    SphygmoCor Unblinded     SphygmoCor Blinded     Total  
Number of Participants  
[units: participants]
  23     27     50  
Age  
[units: years]
Mean ± Standard Deviation
  74  ± 8     72  ± 8     73  ± 8  
Gender  
[units: participants]
     
Female     7     4     11  
Male     16     23     39  
Region of Enrollment  
[units: participants]
     
United States     23     27     50  
Body Mass Index [1]
[units: kg/m^2]
Mean ± Standard Deviation
  29.2  ± 4.5     29.9  ± 4.6     29.6  ± 4.6  
History of Hypertension  
[units: participants]
     
Prior Hypertension     20     26     46  
No Prior Hypertension     3     1     4  
Diabetes  
[units: participants]
     
Prior History of Diabetes     12     12     24  
No History of Diabetes     11     15     26  
Obesity  
[units: participants]
     
Obese at Baseline     10     14     24  
Not Obese at Baseline     13     13     26  
[1] Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.



  Outcome Measures
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1.  Primary:   Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups   [ Time Frame: baseline, 6 months ]

2.  Primary:   Change in Aortic Augmentation Index (AIx) According to Ejection Fraction Subgroups   [ Time Frame: baseline, 6 months ]

3.  Secondary:   Change in Heart Rate   [ Time Frame: baseline, six months ]

4.  Secondary:   Change in Left Ventricle (LV) End Diastolic Volume   [ Time Frame: baseline, 6 months ]

5.  Secondary:   Change in LV End Systolic Volume   [ Time Frame: baseline, 6 months ]

6.  Secondary:   Change in LV Ejection Fraction   [ Time Frame: baseline, 6 months ]

7.  Secondary:   Change in Stroke Volume   [ Time Frame: baseline, 6 months ]

8.  Secondary:   Change in Mitral E Velocity   [ Time Frame: baseline, 6 months ]

9.  Secondary:   Change in Mitral E/A Ratio   [ Time Frame: baseline, 6 months ]

10.  Secondary:   Change in Mitral E Wave Deceleration Time   [ Time Frame: baseline, 6 months ]

11.  Secondary:   Change in Brachial Systolic Blood Pressure (BP)   [ Time Frame: baseline, 6 months ]

12.  Secondary:   Change in Brachial Diastolic BP   [ Time Frame: baseline, 6 months ]

13.  Secondary:   Change in Central Systolic BP   [ Time Frame: baseline, 6 months ]

14.  Secondary:   Change in Central Diastolic BP   [ Time Frame: baseline, 6 months ]

15.  Secondary:   Change in Augmentation Index   [ Time Frame: baseline, 6 months ]

16.  Secondary:   Change in Arterial Elastance   [ Time Frame: baseline, 6 months ]


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


Results Point of Contact:  
Name/Title: Dr. Barry A. Borlaug
Organization: Mayo Clinic
phone: 507-284-4442
e-mail: borlaug.barry@mayo.edu


No publications provided


Responsible Party: Barry Borlaug, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588692     History of Changes
Other Study ID Numbers: 07-002008
Study First Received: December 21, 2007
Results First Received: January 30, 2014
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board