ClinicalTrials.gg
RecruitingNCT05724433VICTORY-HFUpdated Aug 7, 2026

VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

An interventional study of Virtual HF Care and Routine HF Care in Heart Failure, sponsored by Population Health Research Institute. Recruiting at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Population Health Research Institute · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
891
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart Failure
  • Randomized Controlled Trial
  • Digital Health
  • Knowledge Translation
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 891 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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 () \< 1 litre, severe pulmonary hypertension with RVSP > 60 mm Hg, or on home oxygen
  8. Severe kidney disease (persistent \< 30 mL/min/1.73m2)
  9. Active
  10. Receiving palliative care or expected \< 6 months
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
891 participants (estimated)

Study arms

  • Experimental
    Virtual HF care

    Patients will receive virtual HF care to optimize medical therapies

    Other: Virtual HF Care

  • Other
    Routine HF care

    Participants will receive routine HF care

    Other: Routine HF Care

Interventions

  • OtherVirtual 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.

  • OtherRoutine HF Care

    Care as determined by the treating physician

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 and 90 days

  2. Primary "Hierarchical" Composite Outcome of (Part 2):

    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: Time Frame: 30 and 90 Days

  3. 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.

    Time frame: Time Frame: 30 and 90 days.

  4. Co-primary "Hierarchical" Composite Outcome of:

    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.

    Time frame: 90 and 180 days

Secondary outcomes

  1. 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.

    Time frame: 90 days

  2. Clinical Outcomes

    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.

    Time frame: 90 days and 180 days

  3. Healthcare utilization

    i) direct healthcare cost at 90 and 180 days. ii) number of virtual and in-person clinic visits per patient in 90 days.

    Time frame: 90 days and 180 days

07

Study locations

8 of 9 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Sep 2026, 44 months after the start.

Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 44 months is above that.

Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2019
First posted
Feb 13, 2023
StartActual
Jan 23, 2023
Primary completionEst.
Sep 30, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05724433
Responsible party
Harriette Van Spall (Assistant Professor of Medicine, Division of Cardiology, McMaster University, Population Health Research Institute, Population Health Research Institute) — Principal investigator
First posted
Feb 13, 2023
Start date
Jan 23, 2023
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 7, 2026

Study contacts

Harriette GC Van Spall, MD MPH
Contact
Harriette.VanSpall@phri.ca
(905) 521-2100 ext. 40601
VICTORY-HF Project office
Contact
victory-hf@phri.ca
Harriette Van Spall, MD
principal investigator · McMaster University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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