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Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital Boston
Information provided by (Responsible Party):
Mark Alan Creager, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00723801
First received: July 25, 2008
Last updated: September 8, 2014
Last verified: September 2014
Results First Received: August 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Marfan Syndrome
Interventions: Drug: Atenolol
Drug: Losartan

  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
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Reporting Groups
  Description
Subjects Randomized to Atenolol Atenolol: Atenolol 50mg PO QD
Subjects Randomized to Losartan Losartan: Losartan 100mg PO QD

Participant Flow:   Overall Study
    Subjects Randomized to Atenolol     Subjects Randomized to Losartan  
STARTED     20     20  
COMPLETED     17     17  
NOT COMPLETED     3     3  
Lost to Follow-up                 1                 2  
Protocol Violation                 2                 1  



  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
Subjects Randomized to Atenolol Atenolol: Atenolol 50mg PO QD
Subjects Randomized to Losartan Losartan: Losartan 100mg PO QD
Total Total of all reporting groups

Baseline Measures
    Subjects Randomized to Atenolol     Subjects Randomized to Losartan     Total  
Number of Participants  
[units: participants]
  17     17     34  
Age  
[units: years]
Median ( Inter-Quartile Range )
  34  
  ( 25 to 45 )  
  36  
  ( 31 to 44 )  
  35  
  ( 27 to 45 )  
Gender  
[units: participants]
     
Female     10     8     18  
Male     7     9     16  
Pulse wave velocity [1]
[units: meters/second]
Mean ± Standard Deviation
  7.5  ± 1.6     7.6  ± 2.4     7.55  ± 2.0  
Ejection Fraction [2]
[units: %]
Mean ± Standard Deviation
  60  ± 4     62  ± 6     61  ± 5  
[1] Pulse Wave Velocity is a measure of arterial stiffness that is a well-characterized indicator of cardiovascular risk.
[2] Ejection Fraction is a measurement of how much blood volume is ejected from the left ventricle with each contraction. It is a measure of how effectively the heart is pumping blood.



  Outcome Measures
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1.  Primary:   Aortic Biophysical Properties - Pulse Wave Velocity   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Diastolic Function - Ejection Fraction   [ Time Frame: Baseline and 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Creager
Organization: Brigham and Women's Hospital
phone: 617-732-5267
e-mail: mcreager@partners.org


No publications provided


Responsible Party: Mark Alan Creager, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00723801     History of Changes
Other Study ID Numbers: 2007p-001762
Study First Received: July 25, 2008
Results First Received: August 15, 2014
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board