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

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689086
• Other study ID #: CCCiCHF20
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Cambridge Cardiac Care Centre
• Contact: A. Shekhar Pandey, MD
• Phone: (519) 624-3511
• Email: pandey[@]cambridgecardiaccare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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.

Locations

Country	Name	City	State
Canada	Cambridge Cardiac Rehab	Cambridge	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge Cardiac Care Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change from baseline Left Ventricular Ejection Fraction	Measured in Transthoracic Echocardiogram	After completion of program (3 months)
Secondary	Change from baseline NYHA Classification	Stage of Heart Failure (I-IV, IV is worse)	After completion of program (3 months)
Secondary	Change from baseline Left Ventricular Mass Index	Measured by Transthoracic Echocardiogram	After completion of program (3 months)
Secondary	Change from baseline Left Ventricular End Diastolic Diameter	Measured by Transthoracic Echocardiogram	After completion of program (3 months)
Secondary	Change from baseline Left Ventricular End Systolic Diameter	Measured by Transthoracic Echocardiogram	After completion of program (3 months)
Secondary	Change from baseline Serum Potassium		After completion of program (3 months)
Secondary	Change from baseline eGFR		After completion of program (3 months)
Secondary	Change from baseline Systolic Blood Pressure		After completion of program (3 months)
Secondary	Change from baseline Diastolic Blood Pressure		After completion of program (3 months)
Secondary	Change from baseline Heart Rate		After completion of program (3 months)
Secondary	Change from baseline Body Mass Index		After completion of program (3 months)