Heart FailureEVITA-HFNCT01057004
EVIdence Based TreAtment - Heart Failure (EVITA-HF)
An observational study of Heart Failure, run by Stiftung Institut fuer Herzinfarktforschung at 11 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 4,560 participants
- Where
- 11 sitesGermany
- Study dates
- Feb 2009to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- chronical heart failure
- EF ≤ 40 %
Who cannot join
- no informed consent
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Zentralklinikum Augsburg
Augsburg, Bavaria, 86156
Klinikum Links der Weser Bremen
Bremen, Free Hanseatic City of Bremen, 28277
Klinikum Coburg
Coburg, Bavaria, 96450
Klinikum Lippe-Detmold
Detmold, North Rhine-Westphalia, 32756
Universitätsklinikum Essen (Klinik für Kardiologie)
Essen, North Rhine-Westphalia, 45122
Elisabeth - Krankenhaus (Kardiologie) Essen
Essen, North Rhine-Westphalia, 45138
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitätsklinikum des Saarlandes
Homburg/Saar, Saarland, 66421
Klinikum Nürnberg
Nuremberg, Bavaria, 90471
Universitätsklinik Rostock
Rostock, Mecklenburg-Vorpommern, 18057
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all patients | chronical heart failure and EF ≤ 40 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of consecutive patients with chronic cardiac insufficiency and an EF ≤ 40% in hospital daily routine within Germany
Measured: Admission to Hospital and 12 months thereafter
Secondary outcomes (9)
Specification of the medical therapy according to the guidelines
Measured: Admission to hospital and 12 months thereafter
Monitoring of innovations of new therapy possibilities once these are introduced on the market
Measured: 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
Measured: Admission to Hospital and 12 months thereafter
Further interventions during clinical stay, after the index-event
Measured: Index hospital stay
Hospital mortality and non-fatal complications
Measured: Index hospital stay
Mortality and non-fatal complications within the first year
Measured: Admission to Hospital and 12 months thereafter
Symptomatic and frequency of rehospitalisation
Measured: Discharge after index hospital stay and 12 months thereafter
Medicinal and non-medicinal therapy after 12 months
Measured: 12 months after index hospital stay
Association between iron therapy and prognosis in patients with heart failure
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)
Measured: Hospital admission and 12 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Jochen Senges, MD, Principal investigator, Stiftung Institut für Herzinfarktforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057004
- Sponsor's protocol ID
- EVITA-HF
- Acronym
- EVITA-HF
- Status last verified
- Jun 2016
- First submitted
- 26 Jan 2010
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVIdence Based TreAtment - Heart Failure (EVITA-HF)
- ClinicalTrials.gov ID
- NCT01057004
- Acronym / sponsor ID
- EVITA-HF / EVITA-HF
- Conditions
- Heart Failure
- Keywords
- heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,560 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Feb 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | – | –chronical heart failure and EF ≤ 40 % |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- chronical heart failure
- EF ≤ 40 %
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
Specification of the medical therapy according to the guidelines
Time frame: Admission to hospital and 12 months thereafter
Monitoring of innovations of new therapy possibilities once these are introduced on the market
Time frame: 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
Time frame: Admission to Hospital and 12 months thereafter
Further interventions during clinical stay, after the index-event
Time frame: Index hospital stay
Hospital mortality and non-fatal complications
Time frame: Index hospital stay
Mortality and non-fatal complications within the first year
Time frame: Admission to Hospital and 12 months thereafter
Symptomatic and frequency of rehospitalisation
Time frame: Discharge after index hospital stay and 12 months thereafter
Medicinal and non-medicinal therapy after 12 months
Time frame: 12 months after index hospital stay
Association between iron therapy and prognosis in patients with heart failure
Time frame: Hospital admission and 12 months thereafter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Senges, MD principal investigator
Stiftung Institut für Herzinfarktforschung
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Stiftung Institut fuer Herzinfarktforschung at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.