NCT00892112

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

8.6 years

First QC Date

May 1, 2009

Last Update Submit

August 28, 2018

Conditions

Myocardial DiseasesParvovirus B19, Human

Keywords

Immunoglobulins, IntravenousCardiomyopathiesParvo B19, Human

Outcome Measures

Primary Outcomes (1)

  • The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.

    6 months

Secondary Outcomes (1)

  • Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.

    6 months

Study Arms (2)

intravenous immunoglobulins

ACTIVE COMPARATOR

IV, 40 ml/kg over 4 days

Drug: Intravenous Immunoglobulins

plasma volume expander Albuman

PLACEBO COMPARATOR

IV, 40 ml/kg over 4 days

Drug: plasma volume expander

Interventions

Intravenous ImmunoglobulinsDRUG

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

Also known as: Nanogam
intravenous immunoglobulins
plasma volume expanderDRUG

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

Also known as: G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing"), Albuman 40 g/l
plasma volume expander Albuman

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZM

Maastricht, 6229 HX, Netherlands

Location

Related Publications (1)

  • Hazebroek MR, Henkens MTHM, Raafs AG, Verdonschot JAJ, Merken JJ, Dennert RM, Eurlings C, Abdul Hamid MA, Wolffs PFG, Winkens B, Brunner-La Rocca HP, Knackstedt C, van Paassen P, van Empel VPM, Heymans SRB. Intravenous immunoglobulin therapy in adult patients with idiopathic chronic cardiomyopathy and cardiac parvovirus B19 persistence: a prospective, double-blind, randomized, placebo-controlled clinical trial. Eur J Heart Fail. 2021 Feb;23(2):302-309. doi: 10.1002/ejhf.2082. Epub 2021 Jan 7.

    PMID: 33347677DERIVED

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Immunoglobulins, IntravenousPlasma Substitutes

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBlood SubstitutesHematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • S Heymans, PhD, MD

    AZM, Maastricht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 4, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

NL(1)