Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: Octagam (IVIG) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s):
Lars Gullestad, MD, PhD, Principal Investigator
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.
Clinical Details
Official title: Phase III Study of Intravenous Immunglobulin (IVIG) in Patients With Heart Failure After Myocardial Infarction
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI
Secondary outcome: 2. Effect on IVIG on B-Type Natriuretic Peptide (BNP).
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.
IVIG/placebo 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 (i. e., TIMPs) and procollagen III N-terminal.
d. Effect on neurohormones. e. Withdrawals. f. Side effects.
Eligibility
Minimum age: 18 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age of 18-80 years
- Have a recent MI (<5days)
- Have ASAT >100 U/L or CKMB > 50 U/L.
- Have LVEF <40%.
- Are on optimal medical treatment and considered unsuitable for surgical intervention.
Exclusion Criteria:
- Evidence of unstable disease, concomitant ischemia or unstable angina during the
hospitalization.
- Significant concomitant disease such as infections, pulmonary disease or connective
tissue disease.
- Participating in other studies.
- Inability to participate.
- Diseases that require surgery.
- Planned revascularisation.
- Known hypersensitivity to IVIG.
Locations and Contacts
Rikshospitalet University Hospital, Oslo, Norway
Additional Information
Starting date: February 2007
Last updated: January 24, 2014
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