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Trial record 8 of 116 for:    Atenolol

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
Sponsor:
Collaborator:
Boston Children’s Hospital
Information provided by (Responsible Party):
Mark Alan Creager, MD, Brigham and Women's Hospital

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
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects Randomized to Atenolol Subjects Randomized to Losartan
Hide Arm/Group Description Atenolol: Atenolol 50mg PO QD Losartan: Losartan 100mg PO QD
Period Title: Overall Study
Started 20 20
Completed 17 17
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             1             2
Protocol Violation             2             1
Arm/Group Title Subjects Randomized to Atenolol Subjects Randomized to Losartan Total
Hide Arm/Group Description Atenolol: Atenolol 50mg PO QD Losartan: Losartan 100mg PO QD Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
34
(25 to 45)
36
(31 to 44)
35
(27 to 45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
10
  58.8%
8
  47.1%
18
  52.9%
Male
7
  41.2%
9
  52.9%
16
  47.1%
Pulse wave velocity   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters/second
Number Analyzed 17 participants 17 participants 34 participants
7.5  (1.6) 7.6  (2.4) 7.55  (2.0)
[1]
Measure Description: Pulse Wave Velocity is a measure of arterial stiffness that is a well-characterized indicator of cardiovascular risk.
Ejection Fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 17 participants 17 participants 34 participants
60  (4) 62  (6) 61  (5)
[1]
Measure Description: 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.
1.Primary Outcome
Title Aortic Biophysical Properties - Pulse Wave Velocity
Hide Description Aortic stiffness was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, West Ryde, NSW, Sydney, Australia) to measure carotid to femoral artery pulse wave velocity (PWV). With the patient lying supine in a quiet environment, a handheld micromanometer-tipped probe was applied to the skin surface over the carotid and femoral arteries, compressing the vessel wall so that transmural forces within the vessel wall were perpendicular to the arterial surface. The distance from the sternal notch to the sites of carotid and femoral pulse acquisition were measured and inputted into the device to represent the relative distance from the carotid to femoral artery. The calculation of distance divided by time of pulse upstroke relative to the upstroke of the QRS on a 3 lead surface EKG was used by the device to calculate velocity. All recorded measurements met the manufacturer’s quality control standards integrated into the software package.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Randomized to Atenolol Subjects Randomized to Losartan
Hide Arm/Group Description:
Atenolol: Atenolol 50mg PO QD
Losartan: Losartan 100mg PO QD
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: change in meters/second
-1.15  (1.68) -0.22  (.59)
2.Secondary Outcome
Title Diastolic Function - Ejection Fraction
Hide Description Two-dimensional echocardiography was performed using a 3.0 MHz transducer (General Electric VIVID 7). Left ventricular and left atrial dimensions were determined in parasternal long axis views. Left ventricular ejection fraction was calculated using the modified Simpsons calculation in the apical two and four chamber views.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Randomized to Atenolol Subjects Randomized to Losartan
Hide Arm/Group Description:
Atenolol: Atenolol 50mg PO QD
Losartan: Losartan 100mg PO QD
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Change in % ejection fraction
1.31  (4.07) 1.57  (8.29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects Randomized to Atenolol Subjects Randomized to Losartan
Hide Arm/Group Description Atenolol: Atenolol 50mg PO QD Losartan: Losartan 100mg PO QD
All-Cause Mortality
Subjects Randomized to Atenolol Subjects Randomized to Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subjects Randomized to Atenolol Subjects Randomized to Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects Randomized to Atenolol Subjects Randomized to Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Mark Creager
Organization: Brigham and Women's Hospital
Phone: 617-732-5267
EMail: mcreager@partners.org
Layout table for additonal information
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