VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF)

August 4, 2026 updated by: Harriette Van Spall, Population Health Research Institute

VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT

The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Heart failure (HF) is a leading cause of mortality and morbidity across the world. Access to specialized HF clinics remains limited despite evidence that multidisciplinary HF care improves outcomes. VICTORY-HF is an international, multicentre, pragmatic randomized controlled trial evaluating whether a virtual HF clinic, in addition to routine care, improves implementation and clinical outcomes among patients recently discharged following hospitalization or urgent care visits for HF.

Participants will be randomized to a 90-day virtual HF clinic plus routine care or routine care alone. The virtual clinic will provide structured remote follow-up, monitoring, and optimization of guideline-directed medical therapy (GDMT). The trial will evaluate the effect of the intervention on the medication optimization, patient-reported health status (KCCQ-12), all-cause mortality, HF hospitalization, and emergency department visits.

The multi-centre randomized trial (CTO Project ID 4277) was preceded by a pilot randomized controlled trial (HiREB Project ID 5441) to assess the feasibility and acceptability of the intervention, refine virtual care processes, and inform the final trial protocol. Data collected during the pilot phase were limited to feasibility and process outcomes, distinct from the objectives and outcomes of the multi-center randomized controlled trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
891

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Onatrio
      • Hamilton, Onatrio, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
          • Katie Connolly, Dr
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Contact:
          • Harriette Van Spall, Dr
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Hospital Cancer Centre
        • Contact:
          • Serena Gundy, Dr.
      • Thunder Bay, Ontario, Canada
        • Not yet recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Contact:
      • Toronto, Ontario, Canada
  • Tunisia
      • Monastir, Tunisia
        • Recruiting
        • Fattouma Bourguiba Hospital
        • Contact:
      • Sfax, Tunisia
        • Recruiting
        • Hedi Chaker Hospital
        • Contact:
      • Sousse, Tunisia
        • Recruiting
        • Sahloul Hospital
        • Contact:
      • Tunis, Tunisia
        • Recruiting
        • Military Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult patients ≥ 18 years old who:

  1. Are being discharged after hospitalization or urgent visit for HF as

    1. a primary diagnosis or
    2. significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.
  2. Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.
  3. Have NT-proBNP of > 900 pg/ml during hospital admission or within 7 days after discharge from the ED
  4. Have a mailing address for patient or caregiver
  5. Provide verbal consent

Exclusion Criteria:

  1. Died or left hospital before medically advised hospital discharge
  2. Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)
  3. Unable to engage with digital health technology or follow up
  4. Severe valve disease
  5. Recipient of or on waiting list for LVAD or cardiac transplant
  6. Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy
  7. Severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (FEV1) < 1 litre, severe pulmonary hypertension with RVSP > 60 mm Hg, or on home oxygen
  8. Severe kidney disease (persistent eGFR < 30 mL/min/1.73m2)
  9. Active malignancy
  10. Receiving palliative care or expected life expectancy < 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual HF care
Patients will receive virtual HF care to optimize medical therapies
Other: Virtual HF Care
Patients will receive virtual visits for 3 months following hospitalization / emergency department (ED) visit for HF. Physiologic measures will be monitored remotely and therapies will be optimized.
Other: Routine HF care
Participants will receive routine HF care
Other: Routine HF Care
Care as determined by the treating physician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary "Hierarchical" Composite Outcome of (Part 1):
Time Frame: 30 and 90 days
Target dose of beta blockers (BB), angiotensin receptor-neprilysin inhibitor (ARNI) or angiotensin-converting enzyme inhibitor (ACEi) / angiotensin receptor blocker (ARB), mineralocorticoid receptor antagonist (MRA), and sodium-glucose cotransporter-2 inhibitor (SGLT2i) at 90 days.
30 and 90 days
Primary "Hierarchical" Composite Outcome of (Part 2):
Time Frame: Time Frame: 30 and 90 Days

2. Guideline-directed medical therapy (GDMT) intensification at 30 days, defined as:

  1. initiation or up-titration of a beta blocker;
  2. switch from another beta blocker to carvedilol, bisoprolol, or extended-release metoprolol succinate;
  3. initiation or up-titration of an angiotensin-converting enzyme inhibitor (ACE inhibitor), angiotensin receptor blocker (ARB), or angiotensin receptor-neprilysin inhibitor (ARNI);
  4. switch from an angiotensin-converting enzyme inhibitor (ACE inhibitor) or angiotensin receptor blocker (ARB) to an angiotensin receptor-neprilysin inhibitor (ARNI);
  5. initiation or up-titration of a mineralocorticoid receptor antagonist (MRA); or
  6. initiation of a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor).
Time Frame: 30 and 90 Days
Primary "Hierarchical" Composite Outcome of (Part 3):
Time Frame: Time Frame: 30 and 90 days.
Change in health status, as measured by the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days.
Time Frame: 30 and 90 days.
Co-primary "Hierarchical" Composite Outcome of:
Time Frame: 90 and 180 days
  1. All-cause death at 180 days.
  2. Heart failure (HF) hospitalization at 180 days.
  3. All-cause emergency department (ED) visit at 180 days.
  4. Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days.

These Co-Primary Hierarchical Composite Outcomes were the original Primary Outcomes for this trial. The Primary "Original" Outcome listed below applies only to the single-center pilot phase of the trial.
90 and 180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Guideline-Directed Medical Therapy (GDMT) use
Time Frame: 90 days
Achievement of at least 50% of the target doses of beta blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, sodium-glucose cotransporter-2 inhibitors at 90 days.
90 days
Clinical Outcomes
Time Frame: 90 days and 180 days

i) Time to composite all-cause death, heart failure hospitalization, or all-cause emergency department visit at 180 days ii) Components of composite endpoint

  • Time to all-cause death
  • Time to heart failure hospitalization
  • Time to all-cause emergency department visit iii) Change in health status (Kansas City Cardiomyopathy Questionnaire-12 summary score) at 90 days

The Secondary "Original" Outcomes listed below apply only to the single-center pilot phase.
90 days and 180 days
Healthcare utilization
Time Frame: 90 days and 180 days
i) direct healthcare cost at 90 and 180 days. ii) number of virtual and in-person clinic visits per patient in 90 days.
90 days and 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McMaster University
Hamilton Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harriette Van Spall, MD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VICTORY-HF RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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