Heart Failure Efficacy and Research Trial (HEART) Platform
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years (or legal age of majority in participant's country of residence).
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).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Domain Intervention(s)
Other interventionParticipants 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 Comparator
Other interventionParticipants 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Active Domain Intervention(s)Experimental treatment 1 intervention
Group B: Control / Standard of Care ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 365 days (or as defined in domain-specific protocol)Secondary outcomes
1
All-cause mortality
All-cause mortality after randomization.
Time frame
Up to 365 days2
Cardiovascular hospitalization
Occurrence of cardiovascular hospitalization after randomization.
Time frame
Up to 365 days3
Heart failure hospitalization
Occurrence of hospitalization due to worsening heart failure.
Time frame
Up to 365 days4
All-cause hospitalization
Occurrence of any hospitalization for any cause during the follow-up period of up to 365 days.
Time frame
Up to 365 daysLocations
Sponsors and contacts
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University of Alberta
Lead sponsor
Canadian VIGOUR Centre
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: