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

NCT05689086 | Unknown

• 1 other identifier: CCCiCHF20
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change from baseline NYHA Classification

  After completion of program (3 months)

• Change from baseline Left Ventricular Mass Index

  After completion of program (3 months)

• Change from baseline Left Ventricular End Diastolic Diameter

  After completion of program (3 months)

• Change from baseline Left Ventricular End Systolic Diameter

  After completion of program (3 months)

• Change from baseline Serum Potassium

  After completion of program (3 months)

Study Arms (1)

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

Interventions

Virtual Heart Failure Optimization Program OTHER

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.

Program Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cambridge Cardiac Care Centre: lead

Study Sites (1)

Cambridge Cardiac Rehab

Cambridge, Ontario, N1R 6V6, Canada

RECRUITING

Study Officials

• A. Pandey, MD

  Cambridge Cardiac Care Centre

  STUDY CHAIR

Central Study Contacts

A. Shekhar Pandey, MD

CONTACT

(519) 624-3511; pandey@cambridgecardiaccare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 18, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)