EVIdence Based TreAtment - Heart Failure (EVITA-HF) (EVITA-HF)

This study has been completed.
Sponsor:
Collaborator:
Vifor Inc.
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01057004
First received: January 26, 2010
Last updated: June 23, 2016
Last verified: June 2016
  Purpose
EVITA 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.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EVIdence Based TreAtment - Heart Failure (EVITA-HF)

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)


Enrollment: 4560
Study Start Date: February 2009
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
all patients
chronical heart failure and EF ≤ 40 %

Detailed Description:

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 EVITA 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 EVITA 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • chronical heart failure
  • EF ≤ 40 %

Exclusion Criteria:

  • no informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057004

Locations
Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Zentralklinikum Augsburg
Augsburg, Bayern, Germany, 86156
Klinikum Coburg
Coburg, Bayern, Germany, 96450
Klinikum Nürnberg
Nürnberg, Bayern, Germany, 90471
Universitätsklinikum Würzburg
Würzburg, Bayern, Germany, 97080
Universitätsklinik Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Klinikum Lippe-Detmold
Detmold, Nordrhein-Westfalen, Germany, 32756
Universitätsklinikum Essen (Klinik für Kardiologie)
Essen, Nordrhein-Westfalen, Germany, 45122
Elisabeth - Krankenhaus (Kardiologie) Essen
Essen, Nordrhein-Westfalen, Germany, 45138
Universitätsklinikum des Saarlandes
Homburg/Saar, Saarland, Germany, 66421
Klinikum Links der Weser Bremen
Bremen, Germany, 28277
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Vifor Inc.
Investigators
Principal Investigator: Jochen Senges, MD Stiftung Institut für Herzinfarktforschung
  More Information

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01057004     History of Changes
Other Study ID Numbers: EVITA-HF 
Study First Received: January 26, 2010
Last Updated: June 23, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2016