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The Effect of Losartan in Bicuspid Aortic Valve Patients

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ClinicalTrials.gov Identifier: NCT01390181
Recruitment Status : Terminated (Due to low enrollment the decision was made to terminate study prior to final data collection for any individual.)
First Posted : July 8, 2011
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bicuspid Aortic Valve
Thoracic Aortic Aneurysm
Intervention: Drug: Cozaar

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Losartan Cozaar: Angiotensin II Receptor Blocker

Participant Flow:   Overall Study
    Losartan
STARTED   4 
COMPLETED   0 
NOT COMPLETED   4 
Lost to Follow-up                1 
Study Terminated due to Low Accrual                3 



  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
Losartan Cozaar: Angiotensin II Receptor Blocker

Baseline Measures
   Losartan 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  50.0% 
Male      2  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   Inflammatory Markers Levels   [ Time Frame: Baseline and 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
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  More Information

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


Results Point of Contact:  
Name/Title: Anna Booher
Organization: Grand Traverse Heart Associates
phone: 231 935-5800
e-mail: annabooher3@gmail.com



Responsible Party: Anna Booher, University of Michigan
ClinicalTrials.gov Identifier: NCT01390181     History of Changes
Other Study ID Numbers: HUM00048364
First Submitted: June 30, 2011
First Posted: July 8, 2011
Results First Submitted: March 2, 2017
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017