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Completed

NCT Number: NCT01057004

EVIdence Based TreAtment - Heart Failure (EVITA-HF)

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronical heart failure
  • EF ≤ 40 %

Exclusion criteria

  • no informed consent

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Specification of the medical therapy according to the guidelines

    Time frame: Admission to hospital and 12 months thereafter

  2. Monitoring of innovations of new therapy possibilities once these are introduced on the market

    Time frame: Admission to Hospital and 12 months thereafter

  3. 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

  4. Further interventions during clinical stay, after the index-event

    Time frame: Index hospital stay

  5. Hospital mortality and non-fatal complications

    Time frame: Index hospital stay

  6. Mortality and non-fatal complications within the first year

    Time frame: Admission to Hospital and 12 months thereafter

  7. Symptomatic and frequency of rehospitalisation

    Time frame: Discharge after index hospital stay and 12 months thereafter

  8. Medicinal and non-medicinal therapy after 12 months

    Time frame: 12 months after index hospital stay

  9. Association between iron therapy and prognosis in patients with heart failure

    Time frame: Hospital admission and 12 months thereafter

    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)

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Collaborators

  • Vifor Pharma

Registry information

Acronym: EVITA-HF

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2010
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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