Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430885
Status:
COMPLETED
Last Update Posted:
2014-01-27
First Post:
2007-02-01
Brief Title:
Effect of Intravenous Immunglobulin IVIG After Myocardial Infarction
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Phase III Study of Intravenous Immunglobulin IVIG in Patients With Heart Failure After Myocardial Infarction
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:
The instigators hypothesize that IVIG given in the acute phase following MI in patients at risk for developing HF will improve cardiac performance and by attenuating cardiac remodeling in this phase such therapy will prevent the development of chronic HF resulting in long term beneficial effect also after the therapy has been stopped
Detailed Description:
This double-blind placebo-controlled study represents a new approach to cardiovascular disease The project deals with unresolved issues in the intersection between cardiology immunology and molecular biology
IVIGplacebo will be given as an induction therapy for 5 days and thereafter as monthly infusions for 5 months Change in left ventricular remodeling will be assessed at baseline and 6 and 12 months with MRI and echocardiography
The objectives are
1 The primary objective of this study is to evaluate the effect on IVIG on LV remodeling and function LV remodeling will be evaluated with magnetic resonance imaging MRI which offers an unsurpassed precision in the measurements of heart volumes and function End points will be LV-end systolic and diastolic volume LVESV LVEDV regional wall motion score index WMSI and LV-ejection fraction LV-EF
2 The secondary objective of this study is to evaluate the effect on IVIG on the myocardial marker B-Type Natriuretic Peptide BNP BNP is a sensitive marker of the degree of HF besides being a prognostic indicator 18-20
3 The tertiary objective of this study is to evaluate the effect on IVIG on
a Quality of life b Effect on New York Heart Association NYHA functional class c Effect on immunological variables i Inflammatory cytokines such as TNF-alpha IL-6 IL-18 ii Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta iii Chemokines such as monocyte chemoattractant protein 1 IL-8 and CCL21 iv Regulators of hypertrophy such as matrix metalloproteinases their endogenous inhibitors ie TIMPs and procollagen III N-terminal
d Effect on neurohormones e Withdrawals f Side effects
IVIGplacebo will be given as an induction therapy for 5 days and thereafter as monthly infusions for 5 months Change in left ventricular remodeling will be assessed at baseline and 6 and 12 months with MRI and echocardiography
The objectives are
1 The primary objective of this study is to evaluate the effect on IVIG on LV remodeling and function LV remodeling will be evaluated with magnetic resonance imaging MRI which offers an unsurpassed precision in the measurements of heart volumes and function End points will be LV-end systolic and diastolic volume LVESV LVEDV regional wall motion score index WMSI and LV-ejection fraction LV-EF
2 The secondary objective of this study is to evaluate the effect on IVIG on the myocardial marker B-Type Natriuretic Peptide BNP BNP is a sensitive marker of the degree of HF besides being a prognostic indicator 18-20
3 The tertiary objective of this study is to evaluate the effect on IVIG on
a Quality of life b Effect on New York Heart Association NYHA functional class c Effect on immunological variables i Inflammatory cytokines such as TNF-alpha IL-6 IL-18 ii Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta iii Chemokines such as monocyte chemoattractant protein 1 IL-8 and CCL21 iv Regulators of hypertrophy such as matrix metalloproteinases their endogenous inhibitors ie TIMPs and procollagen III N-terminal
d Effect on neurohormones e Withdrawals f Side effects
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 |
|---|---|---|---|
| NFR 175464V50 | None | None | None |