Clinical trial NCT05689086: A Virtual Heart Failure Optimization Program for Guideline Directed Medical Therapy and Cardiac Rehabilitation
Official title: A Virtual Heart Failure Optimization Program for Guideline Directed Medical Therapy and Cardiac Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Cambridge Cardiac Care Centre
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with HFrEF (ejection fraction less than 40%) with New York Heart Association (NYHA) class II or III symptoms

Brief summary: The goal of this study is to test the impact of a virtual heart failure optimization program on uptake of guideline directed medical therapy, participation in cardiac rehabilitation \& impact on echocardiographic parameters.

Detailed description: This is a single center, prospective pre-post cohort study testing a virtual, multi-disciplinary heart failure optimization program for up-titration of guideline directed medical therapy. This nurse and kinesiologist-led program will start and up-titrate patients on GDMT and offer virtual cardiac rehabilitation over a 3-month period.

The investigators hypothesize that this program could safely achieve higher rates of maximally tolerated ARNI, Beta-blocker, MRA and SGLT2i rates, as well as participation in cardiac rehabilitation among HFrEF patient participants. The investigators hypothesize that participation will lead to improved Left Ventricular Ejection Fraction on Echocardiogram.

Eligibility criteria: Inclusion Criteria:

* HFrEF (ejection fraction less than 40%) with New York Heart Association (NYHA) class II or III symptoms
* Adults (\>18 years of age), capable of providing informed consent, English-proficient and with access to a telephone

Exclusion Criteria:

* Patients who are pregnant
* Patients who who are incarcerated
* Cardiac Transplant Patients
* Patients with Left Ventricular Assist Devices

Primary outcomes:
measure: Change from baseline Doses of GDMT
timeFrame: After completion of program (3 months)
measure: Change from baseline Left Ventricular Ejection Fraction
timeFrame: After completion of program (3 months)
Secondary outcomes:
measure: Change from baseline NYHA Classification
timeFrame: After completion of program (3 months)
measure: Change from baseline Left Ventricular Mass Index
timeFrame: After completion of program (3 months)
measure: Change from baseline Left Ventricular End Diastolic Diameter
timeFrame: After completion of program (3 months)
measure: Change from baseline Left Ventricular End Systolic Diameter
timeFrame: After completion of program (3 months)
measure: Change from baseline Serum Potassium
timeFrame: After completion of program (3 months)
measure: Change from baseline eGFR
timeFrame: After completion of program (3 months)
measure: Change from baseline Systolic Blood Pressure
timeFrame: After completion of program (3 months)
measure: Change from baseline Diastolic Blood Pressure
timeFrame: After completion of program (3 months)
measure: Change from baseline Heart Rate
timeFrame: After completion of program (3 months)
measure: Change from baseline Body Mass Index
timeFrame: After completion of program (3 months)
Other outcomes:
Locations:
city: Cambridge
country: Canada
facility: Cambridge Cardiac Rehab
state: Ontario
Study officials:
affiliation: Cambridge Cardiac Care Centre
name: A. Pandey, MD
role: STUDY_CHAIR
References: