Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT04611594
Status:
UNKNOWN
Last Update Posted:
2020-11-02
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Restriction in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'N-terminal pro-BNP', 'timeFrame': '30 days', 'description': 'Variation in plasma NT pro-BNP levels (from the day of hospital discharge to approximately 30 days after).'}], 'secondaryOutcomes': [{'measure': 'Pulmonary ultrasound', 'timeFrame': '30 days', 'description': 'Variation in the total number of B lines in all lung fields measured by ultrasound (from the day of hospital discharge until approximately 30 days after).'}, {'measure': 'Body weight', 'timeFrame': '30 days', 'description': "Variation of the patient's weight in kilograms (from the day of hospital discharge until approximately 30 days after)"}, {'measure': 'Major cardiovascular and non-cardiovascular clinical events', 'timeFrame': '30 days', 'description': 'Hospital admissions and death'}, {'measure': 'Multidisciplinary clinical events related to heart failure', 'timeFrame': '30 days', 'description': 'Six minutes walk test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary ultrasound', 'Fluid restriction', 'Water restriction', 'Congestion'], 'conditions': ['Heart Failure, Systolic', 'Heart Failure; With Decompensation', 'Pulmonary Congestion']}, 'descriptionModule': {'briefSummary': 'There is a concept increasingly consolidated by clinical evidence that at each hospitalization due to HF decompensation there is a substantial loss of quality of life, which is associated with an initial period of great clinical vulnerability, with high rates of rehospitalization and an increased risk of death. The non-pharmacological measures that are widely practiced and recommended for HF patients, such as fluid restriction, specially at the first 30 days after hospital discharge, still lack clearer evidence of their therapeutic efficacy.', 'detailedDescription': 'The need for hospitalization is an important marker of poor prognosis in patients with heart failure. It is estimated that 25% of patients presenting with acute heart failure are readmitted within 30 days. The maintenance of signs and symptoms of congestion at hospital discharge are common causes of hospital readmission. Thus, the reduction of these signs is a goal to be reached during hospitalization so that the chances of readmission are reduced. However, there is evidence that approximately ¼ of the patients are released despite persisting signs of congestive symptoms. It seems plausible to speculate that patients with HF at higher risk of rehospitalization would be those with the greatest chance of benefiting from therapeutic strategies that seek to reduce the congestive state, such as fluid restriction. In this scenario of initial vulnerability after hospitalization for acutely decompensated HF, recent studies have demonstrated a correlation in the number of B lines in the pulmonary ultrasound of patients at the time of hospital discharge and the prediction of frequent clinical outcomes. It was observed that the presence of pattern B, defined as the presence of more than 3 B lines in at least 2 pulmonary fields bilaterally, was associated with a worse prognosis (mortality from all causes and hospitalization due to decompensation). The present study, therefore, will evaluate the effect of outpatient fluid restriction on levels of NT-proBNP in patients who remain with signs of congestion based on pulmonary ultrasound at the bedside during hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital admission for primary diagnosis of acutely decompensated heart failure, regardless of etiology, according to the criteria of the American College of Cardiology;\n* Diagnosis on echocardiography of heart failure with reduced ejection fraction (\\<40%);\n* Presence of pulmonary congestion defined as at least 2 pulmonary fields with more than 3 B lines in each field on pulmonary ultrasound at the time of hospital discharge.\n\nExclusion Criteria:\n\n* Pulmonary fibrosis or other severe disease that changes the image acquisition (significant pleural effusion, severe pulmonary emphysema, previous pneumectomy or lobectomy, primary or metastatic lung cancer, breast implants);\n* Pregnancy;\n* Dialysis renal failure patient;\n* Factors that could hinder follow-up (not returning to the outpatient clinic of Hospital de Clínicas);\n* Disability or refusing to understand and adhere to the protocol;\n* Refusal to sign consent form.'}, 'identificationModule': {'nctId': 'NCT04611594', 'briefTitle': 'Fluid Restriction in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Impact of Fluid Restriction in Patients With Pulmonary Congestion After Discharge From an Acute Decompensated Heart Failure Hospitalization: a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'HCPA 2019-0216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluid restriction', 'description': 'Prescription to ingest approximately 20 ml / kg of ideal weight.', 'interventionNames': ['Behavioral: Fluid restriction']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Prescription to ingest approximately 30 ml / kg of ideal weight, considered a normal amount of daily water intake.'}], 'interventions': [{'name': 'Fluid restriction', 'type': 'BEHAVIORAL', 'description': 'Ingestion of approximately 20 ml / kg of ideal weight,', 'armGroupLabels': ['Fluid restriction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marcelo Nicola Branchi', 'role': 'CONTACT', 'email': 'mnbranchi@hcpa.edu.br', 'phone': '+5554999118717'}], 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Marcelo Nicola Branchi', 'role': 'CONTACT', 'email': 'mnbranchi@hcpa.edu.br', 'phone': '+555499119187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Graduated Program of Federal University Program', 'investigatorFullName': 'Luis Eduardo Paim Rohde', 'investigatorAffiliation': 'Hospital de Clinicas de Porto Alegre'}}}}