Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-30 @ 12:03 PM
Study NCT ID:
NCT01733134
Status:
WITHDRAWN
Last Update Posted:
2024-11-20
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077602', 'term': 'Tolvaptan'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decided to quit funding before any enrollments', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': '9 hours', 'description': 'Dyspnea will be evaluated at 9 hours'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'during hospitalizaton', 'description': 'The length of hospitalization will be compared between the placebo and interventional cohorts'}, {'measure': 'Rehospitalization', 'timeFrame': '30 days', 'description': 'The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute heart failure', 'emergency department', 'copeptin', 'adh antagonists'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure\n2. Dyspnea at rest or minimal exertion per the patient\n3. Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.\n4. Elevated BNP level \\>200 pg/ml, or NTproBNP \\> 1000pg/mL\n5. Able to administer study drug within 8 hours from triage time\n\nInpatient Hospitalized Inclusion Only:\n\nCo-peptin level \\> 27 pmol/L\n\nExclusion Criteria:\n\n1. Unable to provide informed consent\n2. Unable to have 30 day telephone follow up\n3. Not expected to survive past 6 months\n4. On Renal replacement therapy or creatinine \\>3.5\n5. History of allergy or intolerance to Tolvaptan\n6. Suspected Pregnancy\n7. Cardiogenic Shock\n8. Participation in any interventional trial in prior 30 days.\n9. Receiving or planned to receive IV Inotropic therapy\n10. ACS now or in the past 30 days\n11. Treatment with IV infusion vasoactive drugs in the hour prior to enrollment\n12. Temperature \\> 100.5\n13. Heart Failure due to atrial fibrillation with Rapid Ventricular Response\n14. SBP \\< 90 mmHg'}, 'identificationModule': {'nctId': 'NCT01733134', 'acronym': 'ACTIVATE', 'briefTitle': 'Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)', 'organization': {'class': 'OTHER', 'fullName': 'Maisel, Alan, M.D.'}, 'officialTitle': 'Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy', 'orgStudyIdInfo': {'id': 'ACTIVATE117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard therapy plus Tolvaptan', 'description': 'Patient in the interventional group will receive tolvaptan in addition to standard therapy', 'interventionNames': ['Drug: Tolvaptan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard therapy plus placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Tolvaptan', 'type': 'DRUG', 'otherNames': ['Samsca'], 'description': 'Tolvaptan 30 mg. tablet for subjects enrolled prior to first 8 hours of coming to an emergency department. Repeated daily up to 5th day.', 'armGroupLabels': ['Standard therapy plus Tolvaptan']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Patient in the placebo group will receive tolvaptan in addition to standard therapy', 'armGroupLabels': ['Standard therapy plus placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alan S Maisel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisel, Alan, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, {'name': 'Thermo Fisher Scientific, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}