Heart FailureVICTORY-HFNCT05724433
VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization
A study testing Virtual HF Care and Routine HF Care in people with Heart Failure, run by Population Health Research Institute at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Virtual HF Care and Routine HF Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 891 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 23 Jan 2023to 31 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years old who:
- Are being discharged after hospitalization or urgent visit for HF as
- a primary diagnosis or
- 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.
- Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.
- Have NT-proBNP of > 900 pg/ml during hospital admission or within 7 days after discharge from the ED
- Have a mailing address for patient or caregiver
- Provide verbal consent
Who cannot join
- Died or left hospital before medically advised hospital discharge
- Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)
- Unable to engage with digital health technology or follow up
- Severe valve disease
- Recipient of or on waiting list for LVAD or cardiac transplant
- Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy
Show all 10Show fewer
- 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
- Severe kidney disease (persistent eGFR < 30 mL/min/1.73m2)
- Active malignancy
- Receiving palliative care or expected life expectancy < 6 months
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
VICTORY-HF Project office contact
9 sites in 2 countries
Canada5 sites, 5 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Onatrio, L8N 4A6
Katie Connolly, Dr
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Harriette Van Spall, Dr
- Recruiting
Juravinski Hospital Cancer Centre
Hamilton, Ontario, L8V 5C2
Serena Gundy, Dr.
- Not yet recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Vahid Akbari, 807-684-7580, Vahid.Akbari@tbh.net
- Recruiting
Unity Health Toronto
Toronto, Ontario
Peter Mitoff, 416-766-1162, Peter.Mitoff@unityhealth.to
Tunisia4 sites, 4 recruiting
- Recruiting
Fattouma Bourguiba Hospital
Monastir
Semir Nouira, +21673106000, semir.nouira@rns.tn
- Recruiting
Hedi Chaker Hospital
Sfax
Leila Abid, +21674244511, leilaabidt@yahoo.fr
- Recruiting
Sahloul Hospital
Sousse
Riadh Boukef, +21673369411, riadboukef@gmail.com
- Recruiting
Military Hospital
Tunis
Wafa Fehri, +21671391133, wafafehri@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Virtual HF Care, Routine HF Care
- Keywords
- Heart Failure, Randomized Controlled Trial, Digital Health, Knowledge Translation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual HF CareOther
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.
Routine HF CareOther
Care as determined by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Virtual HF care | Experimental | Patients will receive virtual HF care to optimize medical therapies Receives: Other: Virtual HF Care |
| Routine HF care | Other | Participants will receive routine HF care Receives: Other: Routine HF Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary "Hierarchical" Composite Outcome of (Part 1):
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.
Measured: 30 and 90 days
Primary "Hierarchical" Composite Outcome of (Part 2):
- Guideline-directed medical therapy (GDMT) intensification at 30 days, defined as:
- initiation or up-titration of a beta blocker;
- switch from another beta blocker to carvedilol, bisoprolol, or extended-release metoprolol succinate;
- initiation or up-titration of an angiotensin-converting enzyme inhibitor (ACE inhibitor), angiotensin receptor blocker (ARB), or angiotensin receptor-neprilysin inhibitor (ARNI);
- switch from an angiotensin-converting enzyme inhibitor (ACE inhibitor) or angiotensin receptor blocker (ARB) to an angiotensin receptor-neprilysin inhibitor (ARNI);
- initiation or up-titration of a mineralocorticoid receptor antagonist (MRA); or
- initiation of a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor).
Measured: Time Frame: 30 and 90 Days
Primary "Hierarchical" Composite Outcome of (Part 3):
Change in health status, as measured by the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days.
Measured: Time Frame: 30 and 90 days.
Co-primary "Hierarchical" Composite Outcome of:
- All-cause death at 180 days.
- Heart failure (HF) hospitalization at 180 days.
- All-cause emergency department (ED) visit at 180 days.
- 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.
Measured: 90 and 180 days
Secondary outcomes (3)
Guideline-Directed Medical Therapy (GDMT) use
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.
Measured: 90 days
Clinical Outcomes
- 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.
Measured: 90 days and 180 days
Healthcare utilization
- direct healthcare cost at 90 and 180 days. ii) number of virtual and in-person clinic visits per patient in 90 days.
Measured: 90 days and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start23 Jan 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an unblinded parallel multi-center Randomized Controlled Trial (RCT) of virtual HF clinics + routine care versus routine care alone in patients discharged after a hospitalization or urgent/emergency visit for HF. Randomization will be at the level of the patients and stratified by hospital site. Patients and clinicians will be unblinded, but those analyzing data will be blinded. We will adopt a pragmatic approach to this study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 891 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, McMaster University
- Responsible party
- Principal investigator, Harriette Van Spall, Population Health Research Institute
- Investigators
- Harriette Van Spall, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724433
- Sponsor's protocol ID
- VICTORY-HF RCT
- Acronym
- VICTORY-HF
- Status last verified
- Mar 2026
- First submitted
- 31 Aug 2019
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT
- ClinicalTrials.gov ID
- NCT05724433
- Acronym / sponsor ID
- VICTORY-HF / VICTORY-HF RCT
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Randomized Controlled Trial, Digital Health, Knowledge Translation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 891 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, McMaster University
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Feb 2023 (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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is an unblinded parallel multi-center Randomized Controlled Trial (RCT) of virtual HF clinics + routine care versus routine care alone in patients discharged after a hospitalization or urgent/emergency visit for HF. Randomization will be at the level of the patients and stratified by hospital site. Patients and clinicians will be unblinded, but those analyzing data will be blinded. We will adopt a pragmatic approach to this study.
| Arm | Type | Receives |
|---|---|---|
| Virtual HF care | Experimental | Other: Virtual HF CarePatients will receive virtual HF care to optimize medical therapies |
| Routine HF care | Other | Other: Routine HF CareParticipants will receive routine HF care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are being discharged after hospitalization or urgent visit for HF as
- Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.
- Have NT-proBNP of > 900 pg/ml during hospital admission or within 7 days after discharge from the ED
- Have a mailing address for patient or caregiver
- Provide verbal consent
Key exclusion criteria (10 listed)
- Died or left hospital before medically advised hospital discharge
- Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)
- Unable to engage with digital health technology or follow up
- Severe valve disease
- Recipient of or on waiting list for LVAD or cardiac transplant
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 |
|---|---|---|
| Virtual HF CarePatients 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 | Virtual HF care |
| Routine HF CareCare as determined by the treating physician | Other | Routine HF care |
Primary outcome
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.
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).
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.
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.
3 secondary outcomes
Guideline-Directed Medical Therapy (GDMT) use
Time frame: 90 days
Clinical Outcomes
Time frame: 90 days and 180 days
Healthcare utilization
Time frame: 90 days and 180 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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
VICTORY-HF Project office contact
Harriette Van Spall, MD principal investigator
McMaster University
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual HF Care and Routine HF Care in people with Heart Failure, run by Population Health Research Institute at 9 sites in 2 countries.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Harriette GC Van Spall, MD MPH ((905) 521-2100 ext. 40601, Harriette.VanSpall@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary "Hierarchical" Composite Outcome of (Part 1): (time frame: 30 and 90 days). The study lists 4 primary outcomes in all. 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 7 Aug 2026.