Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01145612
Status:
UNKNOWN
Last Update Posted:
2010-08-12
First Post:
2010-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome
Sponsor:
Forteza, Albert, M.D.
Organization:
Study Overview
Official Title:
A Clinical Trial to Assess the Efficacy and Safety of Losartan Versus Atenolol in the Prevention of Progressive Dilation of the Aorta in Patients With Marfan Syndrome.
Status:
UNKNOWN
Status Verified Date:
2010-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
LO-AT-MARFAN01
Brief Summary:
The purpose of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilatation in patients with Marfan syndrome.
Detailed Description:
Marfan syndrome is a genetic disease of the connective tissue. Patients with Marfan syndrome experience an expansion of the aorta that can lead to dissection or rupture of it. This is the main cause of mortality in these patients.
The main objective of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.
The measurement is made by echocardiography, assessing the diameter of the aorta in different zones: valve annulus, sinuses of Valsalva, sinotubular junction, ascending aorta, aortic arch, thoracic and abdominal aorta.
A total number of 150 subjects diagnosed with Marfan syndrome and who meet the diagnostic criteria of Ghent, of both sexes, 75 per treatment group, aged between 5 and 60, will be included in the study. The study is being conducted in two Spanish hospitals.
The treatment is maintained throughout the study period.
The main objective of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.
The measurement is made by echocardiography, assessing the diameter of the aorta in different zones: valve annulus, sinuses of Valsalva, sinotubular junction, ascending aorta, aortic arch, thoracic and abdominal aorta.
A total number of 150 subjects diagnosed with Marfan syndrome and who meet the diagnostic criteria of Ghent, of both sexes, 75 per treatment group, aged between 5 and 60, will be included in the study. The study is being conducted in two Spanish hospitals.
The treatment is maintained throughout the study period.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-001125-97 | EUDRACT_NUMBER | None | View |