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Proteolytic Enzyme Induction Within the Human Myocardial Interstitium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00744211
First Posted: August 29, 2008
Last Update Posted: November 9, 2017
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.
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: November 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition: Heart Disease
Interventions: Drug: 1mg/kg sitaxsentan sodium
Drug: 2mg/kg sitaxsentan sodium
Other: Vehicle

  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
Prospective randomization in a blinded fashion, at the time of elective coronary revascularization or valve replacement requiring cardiopulmonary bypass.

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
Vehicle Saline intravenous bolus
ET-ARA 1mg/kg 1mg/kg sitaxsentan sodium intravenous bolus
ET-ARA 2mg/kg 2mg/kg sitaxsentan sodium intravenous bolus

Participant Flow for 5 periods

Period 1:   Baseline
    Vehicle   ET-ARA 1mg/kg   ET-ARA 2mg/kg
STARTED   10   9   10 
COMPLETED   10   9   10 
NOT COMPLETED   0   0   0 

Period 2:   0.5 Hours After Cardiopulmonary Bypass
    Vehicle   ET-ARA 1mg/kg   ET-ARA 2mg/kg
STARTED   10   9   10 
COMPLETED   10   9   10 
NOT COMPLETED   0   0   0 

Period 3:   6 Hours After Cardiopulmonary Bypass
    Vehicle   ET-ARA 1mg/kg   ET-ARA 2mg/kg
STARTED   10   9   10 
COMPLETED   10   9   10 
NOT COMPLETED   0   0   0 

Period 4:   12 Hours After Cardiopulmonary Bypass
    Vehicle   ET-ARA 1mg/kg   ET-ARA 2mg/kg
STARTED   10   9   10 
COMPLETED   10   9   10 
NOT COMPLETED   0   0   0 

Period 5:   24 Hours After Cardiopulmonary Bypass
    Vehicle   ET-ARA 1mg/kg   ET-ARA 2mg/kg
STARTED   10   9   10 
COMPLETED   10   9   10 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
Vehicle Saline, intravenous bolus
ET-ARA 1mg/kg 1mg/kg sitaxsentan sodium
ET-ARA 2mg/kg 2mg/kg sitaxsentan sodium
Total Total of all reporting groups

Baseline Measures
   Vehicle   ET-ARA 1mg/kg   ET-ARA 2mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   10   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (2)   62  (3)   68  (3)   66  (2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  10.0%      2  22.2%      0   0.0%      3  10.3% 
Male      9  90.0%      7  77.8%      10 100.0%      26  89.7% 
Left Ventricular Ejection Fraction (LVEF) 
[Units: Percent]
Mean (Standard Deviation)
 35  (3)   38  (2)   37  (3)   37  (2) 
Plasma Endothelin 
[Units: fmol/mL]
Mean (Standard Deviation)
 3.9  (0.4)   3.7  (0.3)   4.3  (0.7)   4.0  (0.3) 
Systemic vascular resistance 
[Units: Dyne*second/centimeter˄5]
Mean (Standard Deviation)
 1408  (119)   1359  (210)   1307  (112)   1358  (83) 
Pulmonary vascular resistance 
[Units: Dyne*second/centimeter˄5]
Mean (Standard Deviation)
 153.8  (19.9)   213.0  (65.3)   174.6  (28.4)   180  (23) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pulmonary Vascular Resistance   [ Time Frame: Baseline, 0, 6, 12 and 24 hours post-cardiopulmonary bypass (CPB) ]

2.  Secondary:   Plasma Endothelin-1   [ Time Frame: Baseline, 0, 6, 12 and 24 hours post-CPB ]

3.  Other Pre-specified:   Sitaxsentan Levels   [ Time Frame: 0, 6, 12 and 24 hours post-CPB ]

4.  Other Pre-specified:   Number of Other Adverse Events By Type   [ Time Frame: up to 24-hours post-CPB ]


  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
Small sample size, which in turn can result in a disproportionate number of patients with greater pre-operative risk profiles randomized to one treatment group.


  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: Francis G. Spinale
Organization: University of South Carolina SOM
phone: 803-777-3964
e-mail: cvctrc@uscmed.sc.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00744211     History of Changes
Other Study ID Numbers: SURG-001-07F
First Submitted: August 27, 2008
First Posted: August 29, 2008
Results First Submitted: November 7, 2014
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017