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

• ClinicalTrials.gov Identifier: NCT01057004
• Recruitment Status: Completed
• First Posted: January 27, 2010
• Last Update Posted: June 24, 2016
• Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Collaborator: Vifor Pharma
• Information provided by (Responsible Party): Stiftung Institut fuer Herzinfarktforschung

Study Description

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.

Condition or disease
Heart Failure

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 4560 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: EVIdence Based TreAtment - Heart Failure (EVITA-HF)
• Study Start Date: February 2009
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Groups and Cohorts

Group/Cohort
all patients; chronical heart failure and EF ≤ 40 %

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

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 Pharma

Investigators

• Principal Investigator: Jochen Senges, MD; Stiftung Institut für Herzinfarktforschung

More Information

• Responsible Party: Stiftung Institut fuer Herzinfarktforschung
• ClinicalTrials.gov Identifier: NCT01057004
• Other Study ID Numbers: EVITA-HF
• First Posted: January 27, 2010
• Last Update Posted: June 24, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:

heart failure

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases