Clinical Trial: Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Brief Summary: Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.

Detailed Summary: Registry will include all patients who underwent intracoronary or intramyocardial cell therapy as a part of clinical trials performed at UMC Ljubljana from January 2005 until January 2018. Patients will be followed on regular basis in a dedicated heart failure outpatient clinic, clinical data will be collected and stored in a secure central database. Data will be analyzed in periodic intervals by an independent Data monitoring board in an attempt to better define the predictors of clinical response to cell therapy in this patient population.
Sponsor: University Medical Centre Ljubljana

Current Primary Outcome: Transplantation-free survival [ Time Frame: 5 years ]

Survival after 5 years without undergoing heart transplantation


Original Primary Outcome:

  • Transplantation-free survival [ Time Frame: 5 years ]
    Survival after 5 years without undergoing heart transplantation
  • Change in left ventricular dimensions and function [ Time Frame: 5 years ]
    Changes in left ventricular systolic and diastolic function and left ventricular dimensions and volumes as assessed by echocardiography.


Current Secondary Outcome:

  • Changes in left ventricular ejection fraction [ Time Frame: 5 years ]
  • Changes in left ventricular dimensions [ Time Frame: 5 years ]
  • Changes in left ventricular diastolic function [ Time Frame: 5 years ]
  • Changes in right ventricular function [ Time Frame: 5 years ]


Original Secondary Outcome:

Information By: University Medical Centre Ljubljana

Dates:
Date Received: May 12, 2015
Date Started: January 2005
Date Completion: May 2019
Last Updated: May 2, 2017
Last Verified: May 2017