Clinical trial NCT01057004: EVIdence Based TreAtment - Heart Failure (EVITA-HF)
Official title: EVIdence Based TreAtment - Heart Failure (EVITA-HF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: heart failure
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2010-01-27
Enrollment: 4560
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: 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.

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 criteria: Inclusion Criteria:

* chronical heart failure
* EF ≤ 40 %

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Characteristics of consecutive patients with chronic cardiac insufficiency and an EF ≤ 40% in hospital daily routine within Germany
timeFrame: Admission to Hospital and 12 months thereafter
Secondary outcomes:
measure: Specification of the medical therapy according to the guidelines
timeFrame: Admission to hospital and 12 months thereafter
measure: Monitoring of innovations of new therapy possibilities once these are introduced on the market
timeFrame: Admission to Hospital and 12 months thereafter
measure: Specifications of implantable devices including ICD and CRT as well as the procedure of implantation and the success of the surgical intervention
timeFrame: Admission to Hospital and 12 months thereafter
measure: Further interventions during clinical stay, after the index-event
timeFrame: Index hospital stay
measure: Hospital mortality and non-fatal complications
timeFrame: Index hospital stay
measure: Mortality and non-fatal complications within the first year
timeFrame: Admission to Hospital and 12 months thereafter
measure: Symptomatic and frequency of rehospitalisation
timeFrame: Discharge after index hospital stay and 12 months thereafter
measure: Medicinal and non-medicinal therapy after 12 months
timeFrame: 12 months after index hospital stay
measure: Association between iron therapy and prognosis in patients with heart failure
timeFrame: Hospital admission and 12 months thereafter
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
state: Bayern
city: Coburg
country: Germany
facility: Klinikum Coburg
state: Bayern
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Rostock
country: Germany
facility: Universitätsklinik Rostock
state: Mecklenburg-Vorpommern
city: Detmold
country: Germany
facility: Klinikum Lippe-Detmold
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen (Klinik für Kardiologie)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Elisabeth - Krankenhaus (Kardiologie) Essen
state: Nordrhein-Westfalen
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Bremen
country: Germany
facility: Klinikum Links der Weser Bremen
Study officials:
affiliation: Stiftung Institut für Herzinfarktforschung
name: Jochen Senges, MD
role: PRINCIPAL_INVESTIGATOR
References: