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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00429364
Date of registration: 29/01/2007
Prospective Registration: Yes
Primary sponsor: New England Research Institutes
Public title: Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome--Pediatric Heart Network
Scientific title: Trial of Beta Blocker Therapy (Atenolol) Versus Angiotensin II Receptor Blocker Therapy (Losartan) in Individuals With Marfan Syndrome (A Trial Conducted by the Pediatric Heart Network)
Date of first enrolment: January 2007
Target sample size: 608
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00429364
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Belgium Canada United States
Contacts
Name:     Ron Lacro, MD
Address: 
Telephone:
Email:
Affiliation:  Boston Children’s Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Marfan syndrome, according to Ghent criteria (more information can be
found in Appendix D of the protocol)

- Aortic root Z-score greater than 3.0

Exclusion Criteria:

- Prior aortic surgery

- Aortic root dimension at the sinuses of Valsalva greater than 5 cm

- Planned aortic surgery within 6 months of study entry

- Aortic dissection

- Shprintzen-Goldberg syndrome

- Loeys-Dietz syndrome

- Therapeutic (i.e., for arrhythmia, ventricular dysfunction, or valve regurgitation)
rather than prophylactic use of angiotensin-converting enzyme (ACE) inhibitor,
beta-blocker, or calcium channel blocker

- History of angioedema while taking an ACE inhibitor or beta-blocker

- Intolerance to losartan or other angiotensin II receptor blocker (ARB) that resulted
in termination of therapy

- Intolerance to atenolol or other beta-blocker that resulted in termination of therapy

- Kidney dysfunction (i.e., creatinine greater than the upper limit of age-related
normal values)

- Asthma of sufficient severity to prohibit the use of a beta-blocker

- Chronic use of steroids and/or beta-adrenergic agents with exacerbations of asthma
that are frequent (averaging three or more per year) or severe (requiring
hospitalization)

- Diabetes mellitus

- Pregnant or planning to become pregnant within 36 months of study entry

- Inability to complete study procedures, including history of poor acoustic windows
(i.e., inability to obtain accurate measurement of aortic root)



Age minimum: 6 Months
Age maximum: 25 Years
Gender: All
Health Condition(s) or Problem(s) studied
Marfan Syndrome
Intervention(s)
Drug: Atenolol
Drug: Losartan Potassium
Primary Outcome(s)
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score [Time Frame: Up to 3 years following randomization.]
Secondary Outcome(s)
Adverse Drug Reactions Reported at the Baseline Visit [Time Frame: At baseline]
Adverse Drug Reactions Reported During Routine Follow-up Surveillance [Time Frame: From 6 months to 3 years following randomization.]
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Arm Span to Height Ratio [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area. [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Body Mass Index [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Body Mass Index for Age Z-score [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Height [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Height-for-age Z-score [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in the Absolute Diameter of the Aortic Annulus [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in the Absolute Diameter of the Ascending Aorta [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Upper to Lower Segment Ratio [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Weight [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Weight-for-age Z-score [Time Frame: Up to 3 years following randomization.]
Annual Rate of Change in Weight-for-height Z-score [Time Frame: Up to 3 years following randomization.]
Event Rate of Aortic Dissection. [Time Frame: Up to 3 years following randomization.]
Event Rate of Aortic-Root Surgery [Time Frame: Up to 3 years following randomization.]
Event Rate of Death [Time Frame: Up to 3 years following randomization.]
Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death. [Time Frame: Up to 3 years following randomization.]
Number of Death. [Time Frame: Up to 3 years following randomization.]
Number of Participants With Aortic Dissection. [Time Frame: Up to 3 years following randomization.]
Number of Participants With Aortic-root Surgery. [Time Frame: Up to 3 years following randomization.]
Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death. [Time Frame: Up to 3 years following randomization.]
Secondary ID(s)
461
U01HL068270
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
FDA Office of Orphan Products Development
National Heart, Lung, and Blood Institute (NHLBI)
National Marfan Foundation
Ethics review
Results
Results available: Yes
Date Posted: 01/04/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00429364
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