Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115349
Status:
TERMINATED
Last Update Posted:
2018-03-01
First Post:
2005-06-21
Brief Title:
Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Thalassemia Clinical Research Network - Cardiac L1DFO Trial
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether left ventricular function improves more rapidly with deferoxamine DFO and deferiprone L1 combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions Secondary aims include evaluating changes in myocardial iron burden using T2 and estimating the relative incidence and severity of chelator-induced toxicity
Detailed Description:
DESIGN NARRATIVE
Participants will be randomized to 1 year of treatment with L1DFO combination therapy or DFO monotherapy At baseline 6 months and 1 year on therapy cardiac function will be assessed by MRI measurement of left ventricular ejection fraction LVEF T2 Holter monitoring and electrocardiography Additional monitoring for safety includes weekly blood testing monthly visits and periodic eye and ear exams
Participants will be randomized to 1 year of treatment with L1DFO combination therapy or DFO monotherapy At baseline 6 months and 1 year on therapy cardiac function will be assessed by MRI measurement of left ventricular ejection fraction LVEF T2 Holter monitoring and electrocardiography Additional monitoring for safety includes weekly blood testing monthly visits and periodic eye and ear exams
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 |
|---|---|---|---|
| U01HL065232 | NIH | None | httpsreporternihgovquickSearchU01HL065232 |
| U01HL065260 | NIH | None | None |
| U01HL065244 | NIH | None | None |
| U01HL065239 | NIH | None | None |
| U01HL065238 | NIH | None | None |