Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-04-16 @ 11:00 AM
Study NCT ID:
NCT02599935
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Improvement in Chronic Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-11-17', 'releaseDate': '2020-10-26'}, {'resetDate': '2021-03-04', 'releaseDate': '2021-02-14'}], 'estimatedResultsFirstSubmitDate': '2020-10-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-05', 'studyFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on nutritional status measured with Global Subjective Assesment', 'timeFrame': 'At inclusion , months 3 and 9'}], 'secondaryOutcomes': [{'measure': 'Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement', 'timeFrame': 'At inclusion , months 3 and 9'}, {'measure': 'Change on meters walked in six minutes (functional capacity), after the intervention', 'timeFrame': 'At inclusion , months 3 and 9'}, {'measure': 'Number of readmission.', 'timeFrame': 'at month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutritional status', 'MNA', 'GSA'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'To assess the effect over the nutritional status in patients who are malnourished with chronic heart failure, of an educational intervention and the provision of nutritional supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months', 'detailedDescription': 'Randomized clinical trial with blinded evaluators. (The evaluators will not know the group the patients are assigned. Blinded evaluators are no responsible for randomization and intervention once the patients have been randomized). Patients will be recruited from the cardiology inpatient unit of tertiary hospital, before discharge. Patients will be divided in two groups randomly:\n\nIn one arm will be held a double intervention:\n\n* A structured educational intervention oriented to the patient and primary caregiver, with respect to dietary habits, highly energetic and healthy food, the frequency and manner of eating, exercise and programming breaks.\n* supplementation with dietary supplements, distinguishing one type of product or another, depending on whether the subject to study: diabetes and or kidney failure.\n\nIn the other arm of the study was carried out regular interventions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with the diagnosis of heart failure: who inadvertently lost at least 5% of their "dry weight" in the last six months and / or moderately or severely malnourished according to the GSA and / or at risk or malnourished according to Mini Nutritional Assessment.\n* Willing to participate by accepting and signing an informed consent.\n* On treatment with inhibitors of angiotensin converting enzyme (ACE) inhibitors and / or antagonists of angiotensin II receptors (ARBs) and / or beta blockers.\n\nExclusion Criteria:\n\n* Concurrent active cancer diagnosed.\n* Previous history Dementia or severe cognitive impairment.\n* Participation in another clinical trial simultaneously.\n* Social or health condition that makes the patient impossible to follow the treatment.'}, 'identificationModule': {'nctId': 'NCT02599935', 'acronym': 'VAINICA', 'briefTitle': 'Nutritional Improvement in Chronic Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Impact on Nutrition and Quality of Life of Patients With Heart Failure After a Nurse Intervention on Nutrition Improvement', 'orgStudyIdInfo': {'id': 'PI11/02428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'educational intervention and supplements', 'description': 'structured educational intervention and dietary supplements', 'interventionNames': ['Dietary Supplement: Hypercaloric beverages', 'Other: educational structured counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual interventions', 'description': 'Usual treatment without nutritional supplements or structured assessment', 'interventionNames': ['Other: standard treatment']}], 'interventions': [{'name': 'Hypercaloric beverages', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutritional supplement: Hypercaloric beverages', 'armGroupLabels': ['educational intervention and supplements']}, {'name': 'standard treatment', 'type': 'OTHER', 'description': 'No other than standard treatment', 'armGroupLabels': ['usual interventions']}, {'name': 'educational structured counseling', 'type': 'OTHER', 'description': 'Nutritional counseling leaded to patient and caregivers', 'armGroupLabels': ['educational intervention and supplements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Servicio de Nefrología Hospital General universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Luis Guerra, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario Gregorio Maranon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luis Guerra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nurse', 'investigatorFullName': 'Luis Guerra', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-10-26', 'type': 'RELEASE'}, {'date': '2020-11-17', 'type': 'RESET'}, {'date': '2021-02-14', 'type': 'RELEASE'}, {'date': '2021-03-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Luis Guerra, Nurse, Hospital General Universitario Gregorio Marañon'}}}}