Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2018-06-30

Brief Summary

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A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart.

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Detailed Description

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Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.

Objective: A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination.

Study design: All patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients will be randomized to either receive IVIg or placebo on top of their standard heart failure regimen.

Conditions

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Myocardial Diseases Parvovirus B19, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intravenous immunoglobulins

IV, 40 ml/kg over 4 days

Group Type ACTIVE_COMPARATOR

Intravenous Immunoglobulins

Intervention Type DRUG

2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days

plasma volume expander Albuman

IV, 40 ml/kg over 4 days

Group Type PLACEBO_COMPARATOR

plasma volume expander

Intervention Type DRUG

10 ml/kg BW will be administrated on four consecutive days.

Interventions

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Intravenous Immunoglobulins

2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days

Intervention Type DRUG

plasma volume expander

10 ml/kg BW will be administrated on four consecutive days.

Intervention Type DRUG

Other Intervention Names

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Nanogam G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing") Albuman 40 g/l

Eligibility Criteria

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Inclusion Criteria

* Idiopathic cardiomyopathy (LVEF \<45%) \>6months
* Optimal conventional heart failure medication \>3 months.
* PVB19 viral load \>200 copies/mcg DNA in endomyocardial biopsies (EMBs).
* Signed informed consent
* Aged between 18 and 75 years

Exclusion Criteria

* Other causes for heart failure
* Significant coronary artery disease (lesions \>70 % stenosis)
* Significant valvular disease
* Untreated hypertension (blood pressure \>140mmHg)
* Substance abuse
* Chemotherapy induced
* Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)
* Pregnancy or lactation
* Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
* Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
* Known with allergic reactions against human plasma or plasma products
* Having an ongoing progressive terminal disease, including HIV infection
* Having renal insufficiency (plasma creatinin \>115µmol/L or creatinin clearance \<20 ml/min)
* Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints
* Having detectable anti-IgA antibodies
* Active SLE

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No