Heart FailureHEARTNCT07428135
Heart Failure Efficacy and Research Trial (HEART) Platform
A study testing Domain Intervention(s) in people with Heart Failure, run by University of Alberta.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Domain Intervention(s)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are eligible for inclusion if they meet all of the following:
- Age ≥18 years (or legal age of majority in participant's country of residence).
- Diagnosis of heart failure, and eligible to be classified into one of the HEART platform states at the time of randomization:
- State 1: Worsening Heart Failure (WHF): currently hospitalized for acute decompensated heart failure or emergency department patients requiring intravenous therapy for heart failure; OR
- 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.
- Able and willing to provide written informed consent (or consent via a legally authorized representative, where applicable).
- Meets all applicable domain-specific eligibility criteria for at least one active HEART Platform domain at the time of screening/randomization.
Who cannot join
- Participants will be excluded if any of the following apply:
- Inability to provide informed consent (and no legally authorized representative available when applicable).
- Not eligible for assignment to either HEART platform state (State 1 or State 2).
- 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).
- Does not meet the eligibility requirements for any active HEART Platform domain.
- Any domain-specific exclusion criteria applicable to the intervention/domain(s) for which the participant would otherwise be eligible.
- Additional inclusion and exclusion criteria apply for each individual HEART Platform domain and will be specified in the relevant domain protocol(s).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
HEART 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.
Participants 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.
Each 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.
The 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.
The 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.
- Conditions
- Heart Failure
- Being tested
- Domain Intervention(s), Control / Standard of Care Comparator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domain Intervention(s)Other
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.
Control / Standard of Care ComparatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Domain Intervention(s) | Experimental | 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. Receives: Other: Domain Intervention(s) |
| Control / Standard of Care Comparator | Placebo comparator | 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. Receives: Other: Control / Standard of Care Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of all-cause death or cardiovascular hospitalization
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.
Outcomes 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.
Measured: Up to 365 days (or as defined in domain-specific protocol)
Secondary outcomes (8)
All-cause mortality
All-cause mortality after randomization.
Measured: Up to 365 days
Cardiovascular hospitalization
Occurrence of cardiovascular hospitalization after randomization.
Measured: Up to 365 days
Heart failure hospitalization
Occurrence of hospitalization due to worsening heart failure.
Measured: Up to 365 days
All-cause hospitalization
Occurrence of any hospitalization for any cause during the follow-up period of up to 365 days.
Measured: Up to 365 days
Quality-adjusted days alive and out of the hospital
Number of days alive and out of hospital following randomization, adjusted for health-related quality of life.
Measured: Up to 365 days
Organ-support free days
Number of days alive and free of organ support (e.g., mechanical ventilation, vasopressor therapy, or renal replacement therapy) within 30 days of enrollment.
Measured: Up to 30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
KCCQ Overall Summary Score, a patient-reported measure of heart failure symptoms, physical and social function, and quality of life. Scores range from 0 to 100, with higher scores indicating better health status. Assessed at follow-up time points up to 365 days.
Measured: Up to 365 days
EQ-5D-5L Health Utility Score
Health-related quality of life measured using the EQ-5D-5L instrument. The EQ-5D-5L index score typically ranges from less than 0 (worse than death) to 1 (perfect health), with higher scores indicating better health status. Assessed at follow-up time points up to 365 days.
Measured: Up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2036 (estimated)
- Study completionMar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Responsible party
- Sponsor
- Investigators
- Justin Ezekowitz, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428135
- Sponsor's protocol ID
- HEART-01
- Acronym
- HEART
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Efficacy and Research Trial (HEART) Platform
- ClinicalTrials.gov ID
- NCT07428135
- Acronym / sponsor ID
- HEART / HEART-01
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2036 (estimated)
- Study completion
- Mar 2037 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
HEART 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.
Participants 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.
Each 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.
The 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.
The 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Domain Intervention(s) | Experimental | Other: Domain Intervention(s)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. |
| Control / Standard of Care Comparator | Placebo comparator | Other: Control / Standard of Care ComparatorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants are eligible for inclusion if they meet all of the following:
- Age ≥18 years (or legal age of majority in participant's country of residence).
- Diagnosis of heart failure, and eligible to be classified into one of the HEART platform states at the time of randomization:
- State 1: Worsening Heart Failure (WHF): currently hospitalized for acute decompensated heart failure or emergency department patients requiring intravenous therapy for heart failure; OR
- 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.
Key exclusion criteria (7 listed)
- Participants will be excluded if any of the following apply:
- Inability to provide informed consent (and no legally authorized representative available when applicable).
- Not eligible for assignment to either HEART platform state (State 1 or State 2).
- 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).
- Does not meet the eligibility requirements for any active HEART Platform domain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Domain Intervention(s)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. | Other | Active Domain Intervention(s) |
| Control / Standard of Care ComparatorParticipants 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. | Other | Control / Standard of Care Comparator |
Primary outcome
Time to first occurrence of all-cause death or cardiovascular hospitalization
Time frame: Up to 365 days (or as defined in domain-specific protocol)
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. Outcomes 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.
8 secondary outcomes
All-cause mortality
Time frame: Up to 365 days
Cardiovascular hospitalization
Time frame: Up to 365 days
Heart failure hospitalization
Time frame: Up to 365 days
All-cause hospitalization
Time frame: Up to 365 days
Quality-adjusted days alive and out of the hospital
Time frame: Up to 365 days
Organ-support free days
Time frame: Up to 30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Up to 365 days
EQ-5D-5L Health Utility Score
Time frame: Up to 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Ezekowitz, MD principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A study testing Domain Intervention(s) in people with Heart Failure, run by University of Alberta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Ezekowitz, MD (780-492-0712, jae2@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first occurrence of all-cause death or cardiovascular hospitalization (time frame: Up to 365 days (or as defined in domain-specific protocol)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.