Immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial parvovirus B19 persistence - a prospective, double-blind, randomized, placebo-controlled clinical trial

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

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.
Moreover, the titer of B19-antibodies in the serum of the patients will be
determined before and after infusion, and in the used IVIg product .

A prospective, randomized, double-blind, placebo-controlled trail to evaluate
the effect of IVIg on virus presence and cardiac functional capacity before and
6 months after IVIg therapy.

Intervention: Patients will be randomised into 2 groups. Both groups will
continue with their regular heart failure regimen. Group A will receive a total
dose of 2 gr/kg bodyweight of intravenous immunoglobulin product Nanogam®
administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive
days. Group B will receive placebo, an inactive medication indistinguishable
from the interventional drug. As placebo the plasma volume expander G.P.O. (*
Gepasteuriseerde Plasma-eiwit Oplossing*) is used.

All patients will undergo routine diagnostic work-up, treatment and follow-up
for their heart failure. Patients will be randomized to either receive IVIg or
placebo, G.P.O., on top of their standard heart failure regimen. Patients
receiving IVIg might have benefit from treatment because of elimination of
PVB19. During the infusion the patient will be hospitalized for four days.
Undesirable side effects from plasma products are usualy mild. After 3 month
and 6 months there will be follow-up visits. The visits and investigations are
part of the routine check-up, except for the endomyocardial biopsy (EMB) after
6 months. The procedure to obtain EMBs is a safe one, with a very low risk
(<0.5 %) of peri-procedure complications.
Before the infusion 1 extra blood sample of 10 ml and 3 of 5 ml will be taken.
Moreover, in order to monitor the presence of antibodies against PVB19 and
total IgG levels in total 40 ml blood will be taken in 6 months (3 x 10 ml and
2 x 5 ml). Furthermore, 30 ml (3 x 10ml) blood will be used for future
research. Moreover, at baseline and after 6 months a questionnaire should be
to be filled out.