Status:
COMPLETED
Continuum: Digital Health to Manage Heart Failure Outpatients
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Greybox
Boehringer Ingelheim
Conditions:
Heart Failure
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure (HF) is one of the leading causes of hospitalization and death worldwide. Remote patient monitoring and digital therapeutics could help reduce the consumption of care for these patients ...
Detailed Description
According to Canadian recommendations, patients recently diagnosed with heart failure or with a recent hospitalization should have a medical follow-up every two to four weeks in order to optimize thei...
Eligibility Criteria
Inclusion
- HFC-IN
- Inclusion Criteria:
- HF diagnostic
- NYHA 2 or +
- Active follow-up in heart failure clinic
- Ability to use mobile app (or with caregiver's help)
- And one of the following
- New HF diagnosis (\<3 months)
- Emergency visit or recent hospitalization with decompensated HF (\<6months)
- Increase of \>50% diuretic dose, new diuretic or IV diuretic (last 3 months)
- Active heart failure follow-up 2 times in the last 3 months
- HFC-OUT
- Inclusion Criteria:
- HF diagnostic
- Ability to use mobile app (or with caregiver's help)
- No active follow-up in heart failure clinic or in the waiting list of one
- Exclusion Criteria for HFC-IN and HFC-OUT:
- Active hospitalization at randomization or anticipated in the next 2 weeks
- Incapable or minor patient
- History of non-adherence or treatment refusal
- Alcohol or drugs abuse
- Active major depression without caregiver
- Global prognosis \< 3months
- Active dialysis or on waiting list
- Heart transplant or mechanical heart
- Severe pulmonary disease with oxygen use or pulmonary transplant waiting list or recurrent pleural drainage
- Severe chronic cirrhosis or hepatic transplant waiting list or recurrent ascites drainage
- Percutaneous or surgical intervention in last 30 days or planned in next 3 months
- Pregnancy
- Active follow-up in another study
Exclusion
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2023
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT05377190
Start Date
June 8 2022
End Date
October 24 2023
Last Update
August 9 2024
Active Locations (1)
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1
CRCHUM
Montreal, Quebec, Canada, H2X 0A9