Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-03-06 @ 8:51 AM
Study NCT ID:
NCT02183792
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2014-06-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aquaresis Utility for Hyponatremic Acute Heart Failure Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077602', 'term': 'Tolvaptan'}, {'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tienng@usc.edu', 'phone': '3234421840', 'title': 'Tien Ng, Pharm.D.', 'organization': 'University of Southern California School of Pharmacy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During hospitalization (up to 96 hours post randomization)', 'eventGroups': [{'id': 'EG000', 'title': 'Tolvaptan', 'description': 'Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)\n\nTolvaptan', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Furosemide', 'description': 'Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)\n\nFurosemide', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Urine Output at 24 Hours Post Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolvaptan', 'description': 'Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)\n\nTolvaptan'}, {'id': 'OG001', 'title': 'Furosemide', 'description': 'Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)\n\nFurosemide'}], 'classes': [{'categories': [{'measurements': [{'value': '2910', 'groupId': 'OG000', 'lowerLimit': '1100', 'upperLimit': '4225'}, {'value': '3150', 'groupId': 'OG001', 'lowerLimit': '2375', 'upperLimit': '5680'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours post randomization', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Change in Serum Creatinine at 24 Hours Post Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolvaptan', 'description': 'Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)\n\nTolvaptan'}, {'id': 'OG001', 'title': 'Furosemide', 'description': 'Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)\n\nFurosemide'}], 'classes': [{'title': 'Median Scr at Baseline', 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.51'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '1.22'}]}]}, {'title': 'Median Scr at 24h', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.37'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '-0.19', 'upperLimit': '1.53'}]}]}, {'title': 'Median 24h Change', 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.14', 'upperLimit': '-0.04'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.19', 'upperLimit': '0.15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours post randomization', 'description': 'Comparison between baseline and 24 hours post randomization concentrations.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Urine Output', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Glomerular Filtration Rate (Estimated)', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In-hospital Mortality', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Hourly Urine Output at 24 Hours', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Sodium Change', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Weight Change', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cumulative Furosemide Dose', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cumulative Metolazone Use', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Self-rated Dyspnea', 'timeFrame': 'At baseline, 24 and 96 hours post randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acute Worsening of Kidney Function (Defined as an Increase in Serum Creatinine 0.3 mg/dL or 25% Above Baseline)', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Electrolyte Abnormalities', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Hypo- and hyperkalemia defined as outside the range of 3.5 to 5.0 mEq/L Hypo- and hypermagnesemia defined as outside the range of 1.5-2.4 mEq/L', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Symptomatic Hypotension', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Plasma Renin Activity', 'timeFrame': 'At baseline, 24 and 96 hours post randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Copeptin', 'timeFrame': 'At baseline, 24 and 96 hours post randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in N-terminal Pro-B-type Natriuretic Peptide', 'timeFrame': 'At baseline, 24 and 96 hours post randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Cystatin C', 'timeFrame': 'At baseline, 24 and 96 hours post randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL)', 'timeFrame': 'At baseline, 24, 48, 72 and 96 hours post randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hospital Length of Stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tolvaptan', 'description': 'Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)\n\nTolvaptan'}, {'id': 'FG001', 'title': 'Furosemide', 'description': 'Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)\n\nFurosemide'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tolvaptan', 'description': 'Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)\n\nTolvaptan'}, {'id': 'BG001', 'title': 'Furosemide', 'description': 'Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)\n\nFurosemide'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '59', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '56', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Home Loop Diuretic Dose (Furosemide equivalents)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '93', 'spread': '63.5', 'groupId': 'BG000'}, {'value': '108', 'spread': '77.5', 'groupId': 'BG001'}, {'value': '100', 'spread': '68.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-09', 'size': 347290, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-24T11:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2014-06-25', 'resultsFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-24', 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total Urine Output', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'Glomerular Filtration Rate (Estimated)', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'In-hospital Mortality', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'Mean Hourly Urine Output at 24 Hours', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'Serum Sodium Change', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.'}, {'measure': 'Weight Change', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.'}, {'measure': 'Cumulative Furosemide Dose', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'Cumulative Metolazone Use', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'Change in Self-rated Dyspnea', 'timeFrame': 'At baseline, 24 and 96 hours post randomization'}, {'measure': 'Acute Worsening of Kidney Function (Defined as an Increase in Serum Creatinine 0.3 mg/dL or 25% Above Baseline)', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'Incidence of Electrolyte Abnormalities', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days', 'description': 'Hypo- and hyperkalemia defined as outside the range of 3.5 to 5.0 mEq/L Hypo- and hypermagnesemia defined as outside the range of 1.5-2.4 mEq/L'}, {'measure': 'Symptomatic Hypotension', 'timeFrame': 'Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'Change in Plasma Renin Activity', 'timeFrame': 'At baseline, 24 and 96 hours post randomization'}, {'measure': 'Change in Copeptin', 'timeFrame': 'At baseline, 24 and 96 hours post randomization'}, {'measure': 'Change in N-terminal Pro-B-type Natriuretic Peptide', 'timeFrame': 'At baseline, 24 and 96 hours post randomization'}, {'measure': 'Change in Cystatin C', 'timeFrame': 'At baseline, 24 and 96 hours post randomization'}, {'measure': 'Change in Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL)', 'timeFrame': 'At baseline, 24, 48, 72 and 96 hours post randomization'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days'}], 'primaryOutcomes': [{'measure': 'Median Urine Output at 24 Hours Post Randomization', 'timeFrame': '24 hours post randomization'}], 'secondaryOutcomes': [{'measure': 'Median Change in Serum Creatinine at 24 Hours Post Randomization', 'timeFrame': '24 hours post randomization', 'description': 'Comparison between baseline and 24 hours post randomization concentrations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with worse prognosis. In addition to its prognostic value, hyponatremia may have importance during the acute management of HF. We've recently shown that acute or chronic hyponatremia, especially \\<130 mEq/L, was associated with higher loop diuretic dose requirements and more frequent need for escalation of the diuretic regimen to achieve the same level of diuresis as normonatremic HF patients. Aquaresis with tolvaptan represents a potentially advantageous approach to the management of volume overload in HF, especially in patients presenting with concomitant hyponatremia. The purpose of the current study is to prospectively evaluate the comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to conventional diuresis with a furosemide-based regimen on short-term clinical and treatment outcomes in hyponatremic acute HF patients.\n\nThis will be a prospective, open-label, parallel-group, randomized study comparing a tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based regimen of furosemide. Up to 55 (target sample size of 50) adult subjects admitted with acute HF and signs of volume overload, and serum sodium less than 135 mEq/L will be randomized to tolvaptan or furosemide treatment arms. The initial 24 hours of study treatment will compare tolvaptan monotherapy to furosemide monotherapy. After the initial 24 hours, treatment regimens may be altered to achieve desired clinical goals. Patients will be followed for up to 96 hours and at discharge for study purposes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute HF with signs or symptoms of volume overload \\[i.e. elevated jugular venous pulsation (JVP), rales, edema\\]\n* Serum sodium \\< 135 mEq/L at time of or within first 48 hours of hospitalization\n* Randomized within 48 hours of presentation to hospital\n* ≥ 18 years of age\n* Informed consent\n\nExclusion Criteria:\n\n* Severe symptomatic hyponatremia requiring acute treatment\n* Severe renal impairment upon admission (creatinine clearance \\< 20 mL/min)\n* Renal replacement therapy dependent, or requiring upon admission\n* Acute coronary syndrome on admission\n* Requires or has a mechanical circulatory support device\n* Evidence of cardiogenic shock requiring intravenous vasopressors\n* Pregnancy\n* Patient requiring concomitant use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)'}, 'identificationModule': {'nctId': 'NCT02183792', 'acronym': 'AQUA-AHF', 'briefTitle': 'Aquaresis Utility for Hyponatremic Acute Heart Failure Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Aquaresis Utility for Hyponatremic Acute Heart Failure Study', 'orgStudyIdInfo': {'id': 'HS-13-00705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tolvaptan', 'description': 'Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)', 'interventionNames': ['Drug: Tolvaptan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Furosemide', 'description': 'Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)', 'interventionNames': ['Drug: Furosemide']}], 'interventions': [{'name': 'Tolvaptan', 'type': 'DRUG', 'otherNames': ['Samsca'], 'armGroupLabels': ['Tolvaptan']}, {'name': 'Furosemide', 'type': 'DRUG', 'otherNames': ['Lasix'], 'armGroupLabels': ['Furosemide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC+USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Tien Ng, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'Uri Elkayam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Otsuka America Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Pharmacy and Medicine', 'investigatorFullName': 'Tien Ng', 'investigatorAffiliation': 'University of Southern California'}}}}