Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-30 @ 8:40 PM
Study NCT ID:
NCT01057004
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EVIdence Based TreAtment - Heart Failure (EVITA-HF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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%.\n\nBut 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:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronical heart failure\n* EF ≤ 40 %\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT01057004', 'acronym': 'EVITA-HF', 'briefTitle': 'EVIdence Based TreAtment - Heart Failure (EVITA-HF)', 'organization': {'class': 'OTHER', 'fullName': 'Stiftung Institut fuer Herzinfarktforschung'}, 'officialTitle': 'EVIdence Based TreAtment - Heart Failure (EVITA-HF)', 'orgStudyIdInfo': {'id': 'EVITA-HF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'all patients', 'description': 'chronical heart failure and EF ≤ 40 %'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Zentralklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '96450', 'city': 'Coburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '90471', 'city': 'Nuremberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Nürnberg', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '28277', 'city': 'Bremen', 'state': 'City state Bremen', 'country': 'Germany', 'facility': 'Klinikum Links der Weser Bremen', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '18057', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Universitätsklinik Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '32756', 'city': 'Detmold', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinikum Lippe-Detmold', 'geoPoint': {'lat': 51.93855, 'lon': 8.87318}}, {'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen (Klinik für Kardiologie)', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45138', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Elisabeth - Krankenhaus (Kardiologie) Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '66421', 'city': 'Homburg/Saar', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes'}], 'overallOfficials': [{'name': 'Jochen Senges, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stiftung Institut für Herzinfarktforschung'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stiftung Institut fuer Herzinfarktforschung', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vifor Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}