Continuum HFC-IN for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CRCHUM, Montréal, Canada
Heart Failure+1 More
Continuum HFC-IN - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 (hospitalizations, emergency room visits) and optimize their management (education, medication optimization). This randomized study aims to evaluate the effects of the Continuum software solution in patients with heart failure, whether or not they are followed in specialized clinics. Heart failure is one of the main causes of hospitalization and death in the world. Evidence suggests that remote patient monitoring (RPM) and digital therapeutics (DTX solutions) can help improve care consumption (i.e. hospitalizations, emergency visits) and also support health care professionals to improve care (i.e. symptoms management, drug optimization). This randomised study aims to evaluate the effects of these two software solutions in the context of specialized HF clinics (HFC) and primary health care on health care consumption and clinical events.

Eligible Conditions

  • Heart Failure
  • Congestive heart failure

Treatment Effectiveness

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: 12 weeks

12 weeks
CLIC IN ONLY: Change in guideline-directed medical therapy by classes
CLIC IN ONLY: Change in guideline-directed medical therapy by doses
CLIC IN ONLY: care consumption
CLIC OUT ONLY: Care consumption
CLIC OUT ONLY: Change in guideline-directed medical therapy by classes
CLIC OUT ONLY: Change in guideline-directed medical therapy by dose
MACE and other clinical events
NTproBNP
New York Heart Association class
Pharmacological profile
Quality of life assessment (QoL)

Trial Safety

Trial Design

4 Treatment Groups

For patients followed in a heart failure clinic (HFC), intervention HFC-IN
1 of 4
For patients not followed in a HFC, intervention HFC-OUT
1 of 4
For patients followed in a HFC, control HFC-IN
1 of 4
For patients not followed in a HFC, control HFC-OUT
1 of 4
Experimental Treatment
Non-Treatment Group

400 Total Participants · 4 Treatment Groups

Primary Treatment: Continuum HFC-IN · Has Placebo Group · N/A

For patients followed in a heart failure clinic (HFC), intervention HFC-IN
Other
Experimental Group · 1 Intervention: Continuum HFC-IN · Intervention Types: Other
For patients not followed in a HFC, intervention HFC-OUT
Other
Experimental Group · 1 Intervention: Continuum HFC-OUT · Intervention Types: Other
For patients followed in a HFC, control HFC-IN
Other
PlaceboComparator Group · 1 Intervention: Standard of care for the follow-up · Intervention Types: Other
For patients not followed in a HFC, control HFC-OUT
Other
PlaceboComparator Group · 1 Intervention: Standard of care for the follow-up · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Closest Location: CRCHUM · Montréal, Canada
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2021First Recorded Clinical Trial
1 TrialsResearching Heart Failure
4 CompletedClinical Trials

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
319 Previous Clinical Trials
111,849 Total Patients Enrolled
2 Trials studying Heart Failure
716 Patients Enrolled for Heart Failure
Boehringer IngelheimIndustry Sponsor
2,372 Previous Clinical Trials
9,725,126 Total Patients Enrolled
22 Trials studying Heart Failure
122,134 Patients Enrolled for Heart Failure
GreyboxUNKNOWN
François Tournoux, MD PhDPrincipal InvestigatorCHUM

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have used a diuretic in the past.
You have been hospitalized with decompensated HF for less than 6 months.
You have a high-frequency (HF) diagnostic.
You have been diagnosed with heart failure and you have been followed up in a heart failure clinic.
You are able to use the mobile app.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.