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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Virtual Heart Failure Optimization Program

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: A. Shekhar Pandey, MD; Phone Number: (519) 624-3511; Email: pandey@cambridgecardiaccare.com

Study Locations

• Canada
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
      • Recruiting
      • Cambridge Cardiac Rehab
      • Contact: A. Shekhar Pandey, BSc, MD; Phone Number: (519) 624-3511; Email: pandey@cambridgecardiaccare.com
      • Contact: M. Michelle Pandey, B Pharm; Phone Number: (519) 624-3511; Email: michellepandey@cambridgecardiaccare.com
      • Principal Investigator: A. Pandey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Virtual Heart Failure Optimization Program; Participants referred to the "Virtual Heart Failure Optimization Program" will be seen for initial consultation by a HF program nurse and cardiologist within 1 week. Patients will be offered the opportunity to participate in virtual cardiac rehabilitation. Following this, patients will be assessed virtually every two weeks by a HF program nurse for addition and up-titration of medical therapy. All medication changes will be performed algorithmically and reviewed with the overseeing cardiologist. Following all medication changes, appropriate monitoring will be performed algorithmically as well. All participants will be asked if they would like to participate in cardiac rehabilitation and an automatic referral will be sent by the overseeing cardiologist. Virtual cardiac rehabilitation will be conducted weekly with phone follow-up appointments with a program kinesiologist and virtual education programming.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cambridge Cardiac Care Centre
• Investigators: Study Chair: A. Pandey, MD, Cambridge Cardiac Care Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CCCiCHF20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No