EVIdence Based TreAtment - Heart Failure (EVITA-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Stiftung Institut fuer Herzinfarktforschung
Sponsor:
Collaborator:
Vifor Inc.
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01057004
First received: January 26, 2010
Last updated: June 9, 2011
Last verified: June 2011

January 26, 2010
June 9, 2011
February 2009
December 2015   (final data collection date for primary outcome measure)
Characteristics of consecutive patients with chronic cardiac insufficiency and an EF ≤ 40% in hospital daily routine within Germany [ Time Frame: Admission to Hospital and 12 months thereafter ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057004 on ClinicalTrials.gov Archive Site
  • Specification of the medical therapy according to the guidelines [ Time Frame: Admission to hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Monitoring of innovations of new therapy possibilities once these are introduced on the market [ Time Frame: Admission to Hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Specifications of implantable devices including ICD and CRT as well as the procedure of implantation and the success of the surgical intervention [ Time Frame: Admission to Hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Further interventions during clinical stay, after the index-event [ Time Frame: Index hospital stay ] [ Designated as safety issue: No ]
  • Hospital mortality and non-fatal complications [ Time Frame: Index hospital stay ] [ Designated as safety issue: No ]
  • Mortality and non-fatal complications within the first year [ Time Frame: Admission to Hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Symptomatic and frequency of rehospitalisation [ Time Frame: Discharge after index hospital stay and 12 months thereafter ] [ Designated as safety issue: No ]
  • Medicinal and non-medicinal therapy after 12 months [ Time Frame: 12 months after index hospital stay ] [ Designated as safety issue: No ]
  • Association between iron therapy and prognosis in patients with heart failure [ Time Frame: Hospital admission and 12 months thereafter ] [ Designated as safety issue: No ]
    Analysis of laboratory values of hemoglobin, erythrocytes, reticulocytes, ferritin, serum iron, transferrin, transferrin saturation and their effect on prognosis of heartfailure patients. (RAID-HF substudy to EVITA-HF registry)
  • Specification of the medical therapy according to the guidelines [ Time Frame: Admission to hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Monitoring of innovations of new therapy possibilities once these are introduced on the market [ Time Frame: Admission to Hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Specifications of implantable devices including ICD and CRT as well as the procedure of implantation and the success of the surgical intervention [ Time Frame: Admission to Hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Further interventions during clinical stay, after the index-event [ Time Frame: Index hospital stay ] [ Designated as safety issue: No ]
  • Hospital mortality and non-fatal complications [ Time Frame: Index hospital stay ] [ Designated as safety issue: No ]
  • Mortality and non-fatal complications within the first year [ Time Frame: Admission to Hospital and 12 months thereafter ] [ Designated as safety issue: No ]
  • Symptomatic and frequency of rehospitalisation [ Time Frame: Discharge after index hospital stay and 12 months thereafter ] [ Designated as safety issue: No ]
  • Medicinal and non-medicinal therapy after 12 months [ Time Frame: 12 months after index hospital stay ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
EVIdence Based TreAtment - Heart Failure (EVITA-HF)
EVIdence Based TreAtment - Heart Failure (EVITA-HF)

Cardiac insufficiency is the main or secondary diagnosis of 10% of all hospitalised patients. Due to the age-structure of the population and to the increased life expectancy after myocardial infarction prevalence is increasing. Even though prognosis in patients with established heart failure has been improved it remains serious, with an average survival rate of 50% after 4 years. Approximately 2% of all expenses in health care are caused by cardiac insufficiency, the most expensive being the hospitalization phase. The rehospitalisation rate after the first hospital stay is 50% within 6 months. By optimal, guideline-adjusted therapy during hospital- and post-hospital-stay the rehospitalisation rate could be reduced by 50%.

But our knowledge concerning therapies is based on study results, which are generated with selected patients under controlled study conditions. Thus it is necessary to collect data on the development of therapy, the successes as well as the complications in clinical everyday life. Results concerning the quality of therapies are required and measures are needed that will contribute to quality assurance and improvement. Due to these reasons the DHI register was initiated with the following objectives, aims, structure, and organization form:

The register will not substitute randomized, controlled, multi-center clinical trials (RCT) that have a defined prospective research question. Such randomized studies investigate the "efficacy" of a therapy, i.e. a clinical effect under experimental conditions. In contrast, registers investigate the transferability of RCT results to the daily routine within hospital, the so called "effectiveness". Both study types are complementary and are needed for a judgment of the clinical efficiency as well as of security aspects and possible adverse reactions. Furthermore the DHI register should function as an idea supplier and should coordinate possible future studies. Other important tasks of the register are: (i) the establishment of recommendations for an optimal medicinal therapy (OMT) as well as for ICD- and CRT-treatment; (ii) the establishment of quality assurance measures, including monitoring of new therapy. Every 6 months each study center receives a complete overview concerning the centers own data in comparison with the data supplied by other centers.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

primary care clinic

Heart Failure
Not Provided
all patients
chronical heart failure and EF ≤ 40 %
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
March 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • chronical heart failure
  • EF ≤ 40 %

Exclusion Criteria:

  • no informed consent
Both
Not Provided
No
Contact: Jochen Senges, MD +49 621 503 2801
Germany
 
NCT01057004
EVITA-HF
No
Prof. Dr. med. Jochen Senges, Stiftung Institut für Herzinfarktforschung Ludwigshafen
Stiftung Institut fuer Herzinfarktforschung
Vifor Inc.
Principal Investigator: Jochen Senges, MD Stiftung Institut für Herzinfarktforschung
Stiftung Institut fuer Herzinfarktforschung
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP