EVIdence Based TreAtment - Heart Failure (EVITA-HF)
EVITA-HF
1 other identifier
observational
4,560
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 24, 2016
June 1, 2016
6.8 years
January 26, 2010
June 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Characteristics of consecutive patients with chronic cardiac insufficiency and an EF ≤ 40% in hospital daily routine within Germany
Admission to Hospital and 12 months thereafter
Secondary Outcomes (9)
Specification of the medical therapy according to the guidelines
Admission to hospital and 12 months thereafter
Monitoring of innovations of new therapy possibilities once these are introduced on the market
Admission to Hospital and 12 months thereafter
Specifications of implantable devices including ICD and CRT as well as the procedure of implantation and the success of the surgical intervention
Admission to Hospital and 12 months thereafter
Further interventions during clinical stay, after the index-event
Index hospital stay
Hospital mortality and non-fatal complications
Index hospital stay
- +4 more secondary outcomes
Study Arms (1)
all patients
chronical heart failure and EF ≤ 40 %
Eligibility Criteria
primary care clinic
You may qualify if:
- chronical heart failure
- EF ≤ 40 %
You may not qualify if:
- no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiftung Institut fuer Herzinfarktforschunglead
- Vifor Pharmacollaborator
Study Sites (11)
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Zentralklinikum Augsburg
Augsburg, Bavaria, 86156, Germany
Klinikum Coburg
Coburg, Bavaria, 96450, Germany
Klinikum Nürnberg
Nuremberg, Bavaria, 90471, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Klinikum Links der Weser Bremen
Bremen, City state Bremen, 28277, Germany
Universitätsklinik Rostock
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Klinikum Lippe-Detmold
Detmold, North Rhine-Westphalia, 32756, Germany
Universitätsklinikum Essen (Klinik für Kardiologie)
Essen, North Rhine-Westphalia, 45122, Germany
Elisabeth - Krankenhaus (Kardiologie) Essen
Essen, North Rhine-Westphalia, 45138, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, Saarland, 66421, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jochen Senges, MD
Stiftung Institut für Herzinfarktforschung
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
February 1, 2009
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 24, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share