Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

Phase III Study of Intravenous Immunglobulin (IVIG) in Patients With Heart Failure After Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430885
• Other study ID #: 175464/V50
• Secondary ID: NFR 175464/V50
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2007
• Last updated: January 24, 2014
• Start date: February 2007
• Est. completion date: May 2010

Study information

• Verified date: January 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics CommitteeNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Octagam (IVIG)
Intravenous immunoglobulin 0.4 g/kg given as infusion

Locations

Country	Name	City	State
Norway	Rikshospitalet University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI		2009	No
Secondary	2. Effect on IVIG on B-Type Natriuretic Peptide (BNP).		2009	Yes