Clinical Trial: Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multicentre, Randomized, Double-blind, Prospective Investigation on the Effects of Immunoadsorption on Cardiac Function in Patients With Dilated Cardiomyopathy

Brief Summary: The purpose of this study is to investigate the effects of immunoadsorption and subsequent IgG substitution in patients with dilated cardiomyopathy compared to a control group.

Detailed Summary:

Dilated cardiomyopathy (DCM) is characterized by ventricular chamber enlargement and systolic dysfunction with normal LV wall thickness. According to reports heretofore, the incidence of this disorder in industrialized Western countries lies within the order of magnitude of 5 - 8 new illnesses per year for every 100,000 population. The prevalence, accordingly, is approximately 36 patients for every 100,000 population. However, recent data suggest higher actual prevalence of DCM: at present the estimated prevalence of congestive heart failure ranges from 2% to 6%. According to recently published studies (e.g., the MERIT-HF study and the COPERNICUS study), about 30% to 35% of patients with congestive heart failure suffer from non-ischemic myocardial heart disease. DCM was diagnosed, furthermore, in 12% of the patients of the CIBIS II study. Approximately 26% of the patients with reduced left-ventricular systolic function from the CHARM-added study suffered from heart failure due to DCM. Based on these data, assumption is justified that in Germany approximately 500,000 patients suffer from DCM. Despite advances in medical treatment of heart failure, the general prognosis for DCM is poor. In many cases, treatment options are surgical e.g., heart transplantation or implantation of an assist device.

An association between virus myocarditis and DCM has been hypothesized for a subset of patients with DCM. Both experimental and clinical data indicate that viral infection and inflammatory processes are involved in the pathogenesis of myocarditis and DCM, and may represent important factors causing progression of ventricular dysfunction.

Abnormalities of the cellular immune system are present in patients with myocarditis and DCM. For patients with DCM, immunohistological methods have been introduced for diagnosis of myocardial inflam
Sponsor: University Medicine Greifswald

Current Primary Outcome: Left ventricular ejection fraction (LVEF) at rest, as determined by contrast echocardiography [ Time Frame: six months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical outcome (non-cardiovascular death, cardiovascular death, sudden death, hospitalization for cardiovascular cause/heart failure, acute myocardial infarction, unstable angina, stroke, cardiac interventions/procedures, clinical deterioration) [ Time Frame: 24 months ]
  • LVEF at rest, as determined by contrast echocardiography [ Time Frame: 12 and 24 months ]
  • Reduction of brain natriuretic peptides (BNP and/or NT pro-BNP) [ Time Frame: 6, 12, and 24 months ]
  • Cardiopulmonary exercise capacity [ Time Frame: 6, 12, and 24 months ]
  • LVEF at rest, as determined by magnetic resonance imaging (optional) [ Time Frame: 6, 12, and 24 months ]
  • Serious clinical adverse events [ Time Frame: day 7, 1 month, and 6 months ]
  • Quality of life (MLHFQ) [ Time Frame: 6, 12, and 24 months ]


Original Secondary Outcome:

  • Clinical outcome (non-cardiovascular death, cardiovascular death, sudden death, hospitalization for cardiovascular cause/heart failure, acute myocardial infarction, unstable angina, stroke, cardiac interventions/procedures, clinical deterioration) [ Time Frame: 24 months ]
  • LVEF at rest, as determined by contrast echocardiography [ Time Frame: 12 and 24 months ]
  • Reduction of brain natriuretic peptides (BNP and/or NT pro-BNP) [ Time Frame: 6, 12, and 24 months ]
  • Cardiopulmonary exercise capacity [ Time Frame: 6, 12, and 24 months ]
  • LVEF at rest, as determined by magnetic resonance imaging (optional) [ Time Frame: 6, 12, and 24 months ]
  • Serious clinical adverse events [ Time Frame: 7 dasy, 1 month, and 6 months ]
  • Quality of life (MLHFQ) [ Time Frame: 6, 12, and 24 months ]


Information By: University Medicine Greifswald

Dates:
Date Received: November 14, 2007
Date Started: December 2007
Date Completion: December 2019
Last Updated: May 11, 2017
Last Verified: May 2017