Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429364
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2007-01-29
Brief Title:
Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome--Pediatric Heart Network
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Marfan syndrome is a hereditary connective tissue disorder Many individuals with this condition die because of the associated heart and blood vessel abnormalities This study will compare the effectiveness of two medications losartan and atenolol at slowing aortic root enlargement in individuals with Marfan syndrome
Detailed Description:
Marfan syndrome is an inheritable disorder that affects the bodys connective tissue An abnormal protein results in connective tissue that is weaker than normal Because connective tissue is found throughout the body Marfan syndrome can affect many body systems including the skeleton eyes nervous system skin lungs heart and blood vessels Overall heart and blood vessel abnormalities are the leading cause of death in individuals with Marfan syndrome A common blood vessel abnormality associated with this disease involves the aorta which is the large artery that carries blood away from the heart to the rest of the body The aortic root the portion of the aorta that is attached to the heart may enlarge and tear or even rupture A tear or rupture is considered a life-threatening emergency Recent studies have shown that the medication losartan may reduce aortic root growth and improve heart function The purpose of this study is to compare the effectiveness of losartan versus atenolol at slowing aortic root growth in individuals with Marfan syndrome
This 3-year study will enroll individuals with Marfan syndrome Participants will be randomly assigned to receive either losartan or atenolol on a daily basis All participants will initially receive a low dose of their assigned medication This dose will be gradually increased every 3 to 4 weeks until the maximum tolerated dose is reached A continuous electrocardiogram ECG that monitors heart rate and activity in 24-hour intervals will be used to determine the proper dose increase for each participant Participants will then receive the maximum tolerated dose for the remainder of the study Study visits will occur at baseline and Months 6 12 24 and 36 Each study visit will include a physical examination a medical history review an ECG an echocardiogram and questionnaires Additionally at the baseline study visit blood will be collected for laboratory testing
This 3-year study will enroll individuals with Marfan syndrome Participants will be randomly assigned to receive either losartan or atenolol on a daily basis All participants will initially receive a low dose of their assigned medication This dose will be gradually increased every 3 to 4 weeks until the maximum tolerated dose is reached A continuous electrocardiogram ECG that monitors heart rate and activity in 24-hour intervals will be used to determine the proper dose increase for each participant Participants will then receive the maximum tolerated dose for the remainder of the study Study visits will occur at baseline and Months 6 12 24 and 36 Each study visit will include a physical examination a medical history review an ECG an echocardiogram and questionnaires Additionally at the baseline study visit blood will be collected for laboratory testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL068270 | NIH | None | httpsreporternihgovquickSearchU01HL068270 |