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Trial record 22 of 52 for:    TIMP2

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):
Anna Booher, University of Michigan

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
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Losartan
Hide Arm/Group Description Cozaar: Angiotensin II Receptor Blocker
Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Lost to Follow-up             1
Study Terminated due to Low Accrual             3
Arm/Group Title Losartan
Hide Arm/Group Description Cozaar: Angiotensin II Receptor Blocker
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Inflammatory Markers Levels
Hide Description Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), & Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed because the study terminated prior to data collection for final primary outcome measure.
Arm/Group Title Losartan
Hide Arm/Group Description:
Cozaar: Angiotensin II Receptor Blocker
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months (study was terminated prior to proposed completion)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan
Hide Arm/Group Description Cozaar: Angiotensin II Receptor Blocker
All-Cause Mortality
Losartan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Losartan
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Losartan
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Cardiac disorders   
Increase in Blood Pressure   1/4 (25.00%)  1
Cardiace Disorder   1/4 (25.00%)  1
General disorders   
Fatigue   1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders   
Fall   1/4 (25.00%)  1
Nervous system disorders   
Shingles   1/4 (25.00%)  1
Indicates events were collected by systematic assessment
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
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