Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:05 AM
Study NCT ID:
NCT07428135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Failure Efficacy and Research Trial (HEART) Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Depends on domains'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a randomized platform trial in which multiple therapeutic domains (interventions) may be evaluated concurrently or sequentially over time within a shared master protocol. Participants are assigned to interventions within active domains based on eligibility at the time of randomization. Domains may be added, modified, or closed during the platform lifecycle.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2037-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)', 'timeFrame': 'Baseline to Day 90)', 'description': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score from baseline to Day 5 comparing treatment groups.\n\nThe Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) ranges from 0 to 100, where higher scores indicate fewer heart failure symptoms and better health status, and lower scores indicate more severe symptoms and worse health status.'}, {'measure': 'Safety outcomes (Serious Adverse Events)', 'timeFrame': 'Up to 30 days (or through end of treatment/participation)', 'description': 'Incidence of serious adverse events (SAEs) and adverse events of special interest, as defined in the master protocol and domain protocols.'}], 'primaryOutcomes': [{'measure': 'Time to first occurrence of all-cause death or cardiovascular hospitalization', 'timeFrame': 'Up to 180 days (or as defined in domain-specific protocol)', 'description': 'Time from randomization to the first event of all-cause death or cardiovascular hospitalization. This represents the platform default primary endpoint for Phase III domain evaluations.\n\nOutcomes for each intervention are defined within each HEART Platform domain protocol. The outcome measures listed in this registration represent platform-level outcomes and default endpoints used across domains where applicable.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular hospitalization', 'timeFrame': 'Up to 180 days', 'description': 'Occurrence of cardiovascular hospitalization after randomization.'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to 180 days', 'description': 'All-cause mortality after randomization.'}, {'measure': 'Heart failure hospitalization', 'timeFrame': 'Up to 180 days', 'description': 'Occurrence of hospitalization due to worsening heart failure.'}, {'measure': 'Days Alive and Out of Hospital', 'timeFrame': 'Up to 180 days', 'description': 'Number of days alive and out of hospital following randomization.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The Heart Failure Efficacy and Research Trial (HEART) Platform is a multicenter, randomized platform study designed to improve outcomes for patients with heart failure through the simultaneous and sequential evaluation of multiple interventions across the spectrum of heart failure.', 'detailedDescription': 'The Heart Failure Efficacy and Research Trial (HEART) Platform is a multicenter, randomized platform clinical trial infrastructure designed to improve outcomes for adults with heart failure through the efficient and continuous evaluation of multiple interventions. The platform enables the simultaneous and sequential testing of therapies across the spectrum of heart failure, with the ability to add, modify, or close interventions ("domains") over time as evidence accumulates and new research questions emerge.\n\nHEART uses a master protocol framework with Domain-Specific Appendices (DSAs) that provide intervention-specific eligibility criteria, procedures, safety monitoring, and outcomes, while using shared platform-wide processes for governance, operations, data collection, and participant protections. This modular documentation structure allows platform updates and domain evolution without requiring complete revisions to all platform components, supporting long-term sustainability and reduced regulatory burden.\n\nParticipants are enrolled into one of two mutually exclusive patient states at the time of randomization: (1) State 1: Worsening Heart Failure (WHF), which includes patients hospitalized or treated in the emergency department for acute heart failure requiring active management; and (2) State 2: Ambulatory Heart Failure, which includes stable outpatients with established heart failure receiving ongoing management and without recent heart failure hospitalization. Patient state determines eligibility for specific domains and supports state-specific analyses.\n\nEach HEART domain operates as a semi-autonomous trial within the broader infrastructure, with domain-specific scientific leadership and funding, while benefiting from shared core trial procedures. Domains may be conducted as vanguard/feasibility studies, Phase II trials, or Phase III trials, depending on the maturity of evidence and research objectives, and interventions may advance ("graduate") to later-phase evaluations within the platform.\n\nThe default primary endpoint for Phase III trials within the platform is time to first event of death or cardiovascular hospitalization; however, specific primary outcomes are determined at the domain level to match the intervention and development phase.\n\nThe HEART Platform incorporates formal governance and safety oversight, including a Platform Steering Committee and independent Data Safety Monitoring Board (DSMB), with standardized adverse event definitions and reporting procedures. The platform is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements, with ethics approval obtained for the master protocol and each individual domain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (HEART Platform)\n\n* Participants are eligible for inclusion if they meet all of the following:\n* Age ≥18 years (or legal age of majority in participant's country of residence).\n* Diagnosis of heart failure, and eligible to be classified into one of the HEART platform states at the time of randomization:\n* State 1: Worsening Heart Failure (WHF): currently hospitalized for acute decompensated heart failure or emergency department patients requiring intravenous therapy for heart failure; OR\n* State 2: Ambulatory Heart Failure: stable outpatients with established heart failure diagnosis, receiving ongoing HF management and without HF hospitalization within the prior 30 days.\n* Able and willing to provide written informed consent (or consent via a legally authorized representative, where applicable).\n* Meets all applicable domain-specific eligibility criteria for at least one active HEART Platform domain at the time of screening/randomization.\n\nExclusion Criteria (HEART Platform)\n\n* Participants will be excluded if any of the following apply:\n* Inability to provide informed consent (and no legally authorized representative available when applicable).\n* Not eligible for assignment to either HEART platform state (State 1 or State 2).\n* Presence of conditions or circumstances that, in the investigator's opinion, would make study participation unsafe or not feasible (e.g., inability to comply with study procedures or follow-up).\n* Does not meet the eligibility requirements for any active HEART Platform domain.\n* Any domain-specific exclusion criteria applicable to the intervention/domain(s) for which the participant would otherwise be eligible.\n* Additional inclusion and exclusion criteria apply for each individual HEART Platform domain and will be specified in the relevant domain protocol(s)."}, 'identificationModule': {'nctId': 'NCT07428135', 'acronym': 'HEART', 'briefTitle': 'Heart Failure Efficacy and Research Trial (HEART) Platform', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Heart Failure Efficacy and Research Trial (HEART) Platform', 'orgStudyIdInfo': {'id': 'HEART-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Domain Intervention(s)', 'description': 'Participants will be randomized to receive one of the active intervention strategies being evaluated within eligible HEART Platform domains at the time of randomization. Eligible domains and interventions may change over time as domains are initiated, modified, or closed.', 'interventionNames': ['Other: Domain Intervention(s)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control / Standard of Care Comparator', 'description': 'Participants will be randomized to a concurrent control group within eligible HEART Platform domains. The control group may include placebo and/or standard-of-care management, as specified in each active domain protocol.', 'interventionNames': ['Other: Control / Standard of Care Comparator']}], 'interventions': [{'name': 'Domain Intervention(s)', 'type': 'OTHER', 'description': 'Participants randomized to the experimental arm will receive an intervention being evaluated within an eligible HEART Platform domain at the time of randomization. Domain interventions may change over time as domains are added, modified, or closed in accordance with the platform master protocol and domain-specific protocols.', 'armGroupLabels': ['Active Domain Intervention(s)']}, {'name': 'Control / Standard of Care Comparator', 'type': 'OTHER', 'description': 'Participants randomized to the comparator arm will receive concurrent control within eligible HEART Platform domains. Control may include placebo and/or standard-of-care management, depending on the domain-specific protocol.', 'armGroupLabels': ['Control / Standard of Care Comparator']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Justin Ezekowitz, MD', 'role': 'CONTACT', 'email': 'jae2@ualberta.ca', 'phone': '780-492-0712'}], 'overallOfficials': [{'name': 'Justin Ezekowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian VIGOUR Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}