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Trial record 21 of 116 for:    Atenolol

Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS

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ClinicalTrials.gov Identifier: NCT01715207
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : May 4, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Duk-Kyung Kim, Samsung Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Marfan Syndrome
Interventions Drug: Aliskiren
Drug: Atenolol
Enrollment 30
Recruitment Details  
Pre-assignment Details The study was premature termination due to the stop of supporting medication from company.
Arm/Group Title Atenolol & Aliskiren Atenolol
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Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month

Aliskiren

Atenolol

Atenolol tablet(Negative controls, Open-label)

Atenolol

Period Title: Overall Study
Started 15 15
Completed 14 14
Not Completed 1 1
Arm/Group Title Atenolol & Aliskiren Atenolol Total
Hide Arm/Group Description

Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month

Aliskiren

Atenolol

Atenolol tablet(Negative controls, Open-label)

Atenolol

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Yeaars
Number Analyzed 14 participants 14 participants 28 participants
32.1  (9.3) 33.2  (12.0) 32.6  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
8
  57.1%
5
  35.7%
13
  46.4%
Male
6
  42.9%
9
  64.3%
15
  53.6%
1.Primary Outcome
Title Central Aortic Distensibility by MRI
Hide Description Analyses of the MRIs were performed using commercial software (Argus version 4.02, Siemens Medical Systems, Germany) by experienced observers who were blinded to patient information. To measure central aortic distensibility, the systolic and diastolic cross-sectional areas were measured by manual contouring of the aorta through the cardiac cycle on the cine image. Distensibility at the four regions was calculated as the mean of values obtained from the following equation: Distensibility = (Amax - Amin)/[Amin × (Pmax - Pmin)](10-3mm/Hg), where Amax is the maximal (systolic) aortic area, Amin is the minimal (diastolic) aortic area, Pmax is the systolic blood pressure (SBP), and Pmin is the diastolic blood pressure (DBP). Central aortic blood pressure measured non-invasively by SphygmoCor was used for systolic and diastolic blood pressure.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.
Arm/Group Title Atenolol & Aliskiren Atenolol
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Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month

Aliskiren

Atenolol

Atenolol tablet(Negative controls, Open-label)

Atenolol

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: (mmHg ^ -1) x 10 ^ -3
initial ascending aorta 3.7  (1.3) 4.7  (2.8)
initial upper descending aorta 5.7  (1.8) 5.1  (2.5)
initial lower descending aorta 7.5  (2.7) 6.3  (2.7)
initial abdominal aorta 2.4  (1.7) 2.7  (1.3)
follow up ascending aorta 5.2  (2.7) 5.0  (2.9)
follow up upper descending aorta 8.3  (4.7) 6.0  (2.8)
follow up lower descending aorta 9.7  (4.6) 7.1  (2.9)
follow up abdominal aorta 4.5  (3.4) 3.5  (1.9)
2.Secondary Outcome
Title Central Aortic PWV(Pulsed Wave Velocity)
Hide Description Aortic PWV was measured according to the well-validated method using MRI 19. From the velocity-encoded MRIs, aortic contours were automatically detected and manually adjusted in each slice area throughout the cardiac cycle. The transit time between the flow curves of each region of the aorta was determined from the midpoint of the systolic up-slope on the flow versus time curve 26-28. The up-slopes were identified by drawing a line between the points of 40% and 60% maximum velocity on the waveform. The distance between each aortic level was measured on black blood images using a curved line along the center of the aorta. Based on these data, the regional PWV was calculated as the ratio of the distance between levels and the time differences between the arrival of the pulse wave at each level. The PWV was measured at two regions: the proximal aorta (proximal PWV between level 1 and level 2) and the entire aorta (PWV-total between level 1 and level 4).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.
Arm/Group Title Atenolol and Aliskiren Atenolol
Hide Arm/Group Description:
Aliskiren (Norvatis) 300mg oral tablet

Atenolol tablet(Negative controls, Open-label)

Control group baseline 24 Weeks Central PWV (m/s)(26) by MRI regional PWV A (level 1-2) 3.8 (1.7) 3.6 (1.23) PWV-total (level 1-4) 5.0 (1.03) 4.9 (1.24)

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: m/s
baseline regional PWV A 3.3  (1.03) 3.8  (1.7)
baseline PWV total 4.5  (0.77) 5.0  (1.03)
follow up regional PWV A 3.2  (0.8) 3.6  (1.23)
follow up PWV total 4.7  (1.1) 4.9  (1.24)
Time Frame 6months
Adverse Event Reporting Description angioedema, GI symptom, rash, gout, hypotension, renal stone K, EKG, creatinine, uric acid, urine analysis Safety information will be collected including all AEs (adverse events) and all SAEs (Serious adverse events). Specially, a serious adverse event form should be completed for all serious adverse events during the study period. The serious adverse event will be checked by investigators. And investigators will report all SAEs to Novartis Safety desk within 24 hours since they know.
 
Arm/Group Title Atenolol & Aliskiren Atenolol
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Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month

Treatment (n=14) Overall rate of adverse events 12 (85.7%) moderate to severe cases 0 generalized symptoms 8 (57.1%) gastrointestinal symptoms 4 (28.6%) lung problems 0 cardiovascular symptoms 3 (21.4%) central nervous system symptoms 5 (35.7%) Eye, nose, throat symptoms 4 (28.6%) gynecologic problems 1 (7.1%) problems of extremities 1 (7.1%)

Atenolol tablet(Negative controls, Open-label)

Control (n=14) Overall rate of adverse events 10 (71.4%) moderate to severe cases 2 (14.3%) generalized symptoms 4 (28.6%) gastrointestinal symptoms 3 (21.4%) lung problems 1 (7.1%) cardiovascular symptoms 0 central nervous system symptoms 1 (7.1%) Eye, nose, throat symptoms 1 (7.1%) gynecologic problems 1 (7.1%) problems of extremities 2 (14.3%)

All-Cause Mortality
Atenolol & Aliskiren Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atenolol & Aliskiren Atenolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      0/14 (0.00%)    
Gastrointestinal disorders     
inguinal hernia   1/14 (7.14%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
pneumothorax   1/14 (7.14%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atenolol & Aliskiren Atenolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/14 (57.14%)      4/14 (28.57%)    
General disorders     
generalized symptoms   8/14 (57.14%)  8 4/14 (28.57%)  4
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Duk-Kyung Kim
Organization: SamsungMC
Phone: 01099333413
EMail: dukkyung.kim@samsung.com
Layout table for additonal information
Responsible Party: Duk-Kyung Kim, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01715207     History of Changes
Other Study ID Numbers: 2009-10-025
First Submitted: October 24, 2012
First Posted: October 26, 2012
Results First Submitted: November 21, 2016
Results First Posted: May 4, 2017
Last Update Posted: June 5, 2017