Heart Failure Efficacy and Research Trial (HEART) Platform

NCT07428135 | Not Yet Recruiting DMC

• 1 other identifier: HEART-01
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Failure

Outcome Measures

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.

  Up to 180 days (or as defined in domain-specific protocol)

Secondary Outcomes (4)

• Cardiovascular hospitalization

  Up to 180 days

• All-cause mortality

  Up to 180 days

• Heart failure hospitalization

  Up to 180 days

• Days Alive and Out of Hospital

  Up to 180 days

Other Outcomes (2)

• Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)

  Baseline to Day 90)

• Safety outcomes (Serious Adverse Events)

  Up to 30 days (or through end of treatment/participation)

Study Arms (2)

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.

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.

Other: Control / Standard of Care Comparator

Interventions

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.

Active Domain Intervention(s)

Control / Standard of Care Comparator OTHER

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.

Control / Standard of Care Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian VIGOUR Centre: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Justin Ezekowitz, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Ezekowitz, MD

CONTACT

780-492-0712; jae2@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Depends on domains
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2036
• Study Completion (Estimated): March 1, 2037
• Last Updated: May 7, 2026

Record last verified: 2026-05