VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (NCT05724433) | Clinical Trial Compass
RecruitingNot Applicable
VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization
Canada, Tunisia891 participantsStarted 2023-01-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary "Hierarchical" Composite Outcome of (Part 1):
Timeframe: 30 and 90 days
2
Primary "Hierarchical" Composite Outcome of (Part 2):
Timeframe: Time Frame: 30 and 90 Days
3
Primary "Hierarchical" Composite Outcome of (Part 3):
. 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)