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Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Rikshospitalet University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Helse Stavanger HF
Information provided by:
Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:
NCT00430885
First received: February 1, 2007
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
 Drug: Octagam (IVIG)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of Intravenous Immunglobulin (IVIG) in Patients With Heart Failure After Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rikshospitalet University Hospital:

Primary Outcome Measures:
  • 1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2. Effect on IVIG on B-Type Natriuretic Peptide (BNP). [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Octagam (IVIG)
    Intravenous immunoglobulin 0.4 g/kg given as infusion
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

Ages Eligible for Study:   18 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430885

Locations
Norway
Rikshospitalet University Hospital
Oslo, Norway
Sponsors and Collaborators
Rikshospitalet University Hospital
Helse Stavanger HF
Investigators
Principal Investigator: Lars Gullestad, MD, PhD
  More Information

No publications provided

Responsible Party: Lars Gullestad, Rikshospitalet University Hospital
ClinicalTrials.gov Identifier: NCT00430885     History of Changes
Other Study ID Numbers: 175464/V50, NFR 175464/V50
Study First Received: February 1, 2007
Last Updated: July 30, 2009
Health Authority: Norway: Ethics Committee
Norway: Norwegian Medicines Agency

Keywords provided by Rikshospitalet University Hospital:
Heart failure
Myocardial infarction
Patients with acute myocardial infarction

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Vascular Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013