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

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ClinicalTrials.gov Identifier: NCT00723801
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : September 1, 2014
Last Update Posted : September 9, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Marfan Syndrome
Interventions: Drug: Atenolol
Drug: Losartan

  Participant Flow

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
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 
Lost to Follow-up                1                2 
Protocol Violation                2                1 

  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
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 
Overall Participants Analyzed 
[Units: Participants]
 17   17   34 
[Units: Years]
Median (Inter-Quartile Range)
 (25 to 45) 
 (31 to 44) 
 (27 to 45) 
[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) 
[1] Pulse Wave Velocity is a measure of arterial stiffness that is a well-characterized indicator of cardiovascular risk.
Ejection Fraction [1] 
[Units: %]
Mean (Standard Deviation)
 60  (4)   62  (6)   61  (5) 
[1] 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

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

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
No text entered.

  More Information

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

Responsible Party: Mark Alan Creager, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00723801     History of Changes
Other Study ID Numbers: 2007p-001762
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: August 15, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 9, 2014