NCT07428135

Heart Failure Efficacy and Research Trial (HEART) Platform

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	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	Control / Standard of Care Comparator	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2036-03-01
• Completion: 2037-03-01
• First posted: 2026-02-23
• Last updated: 2026-02-23