A Virtual Heart Failure Optimization Program for Guideline Directed Medical Therapy and Cardiac Rehabilitation

Recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Other: Virtual Heart Failure Optimization Program

• Registration Number: NCT05689086
• Lead Sponsor: Cambridge Cardiac Care Centre

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-12-13
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-15
• Last Update Submitted: 2023-01-15
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Program Participants	Virtual Heart Failure Optimization Program	Patients with HFrEF (LVEF\<40%) \& NYHA class II-III who are referred to and consent to participate in the "Virtual Heart Failure Optimization Program"

Primary Outcome Measures

Name	Time	Method
Change from baseline Doses of GDMT	After completion of program (3 months)	Beta-blocker, ACE-inhibitor/Angiotensin receptor blocker/Valsartan-Sacubitril, Mineralocorticoid Receptor Antagonist, SGLT2 inhibitor
Change from baseline Left Ventricular Ejection Fraction	After completion of program (3 months)	Measured in Transthoracic Echocardiogram

Secondary Outcome Measures

Name	Time	Method
Change from baseline NYHA Classification	After completion of program (3 months)	Stage of Heart Failure (I-IV, IV is worse)
Change from baseline Serum Potassium	After completion of program (3 months)
Change from baseline Left Ventricular End Systolic Diameter	After completion of program (3 months)	Measured by Transthoracic Echocardiogram
Change from baseline Left Ventricular End Diastolic Diameter	After completion of program (3 months)	Measured by Transthoracic Echocardiogram
Change from baseline eGFR	After completion of program (3 months)
Change from baseline Diastolic Blood Pressure	After completion of program (3 months)
Change from baseline Heart Rate	After completion of program (3 months)
Change from baseline Body Mass Index	After completion of program (3 months)
Change from baseline Left Ventricular Mass Index	After completion of program (3 months)	Measured by Transthoracic Echocardiogram
Change from baseline Systolic Blood Pressure	After completion of program (3 months)

Trial Locations

Locations (1)

Cambridge Cardiac Rehab; 🇨🇦 Cambridge, Ontario, Canada