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

Myocardial Diseases Clinical Trial

Official title:

Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892112
• Other study ID #: MD2009.01
• Status: Completed
• Phase: Phase 3
• Start date: November 2009
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: Sanquin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Myocardial Diseases
• Parvovirus B19, Human

Intervention

Drug:
• 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
• plasma volume expander
10 ml/kg BW will be administrated on four consecutive days.

Locations

Country	Name	City	State
Netherlands	AZM	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Sanquin

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.		6 months
Secondary	Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.		6 months