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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05689086
Enrollment
400
Registered
2023-01-18
Start date
2020-01-01
Completion date
2023-12-31
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Reduced Ejection Fraction

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.

Interventions

OTHERVirtual 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.

Sponsors

Cambridge Cardiac Care Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Left Ventricular Ejection FractionAfter completion of program (3 months)Measured in Transthoracic Echocardiogram
Change from baseline Doses of GDMTAfter completion of program (3 months)Beta-blocker, ACE-inhibitor/Angiotensin receptor blocker/Valsartan-Sacubitril, Mineralocorticoid Receptor Antagonist, SGLT2 inhibitor

Secondary

MeasureTime frameDescription
Change from baseline Left Ventricular End Diastolic DiameterAfter completion of program (3 months)Measured by Transthoracic Echocardiogram
Change from baseline Left Ventricular End Systolic DiameterAfter completion of program (3 months)Measured by Transthoracic Echocardiogram
Change from baseline Serum PotassiumAfter completion of program (3 months)
Change from baseline eGFRAfter completion of program (3 months)
Change from baseline NYHA ClassificationAfter completion of program (3 months)Stage of Heart Failure (I-IV, IV is worse)
Change from baseline Diastolic Blood PressureAfter completion of program (3 months)
Change from baseline Heart RateAfter completion of program (3 months)
Change from baseline Body Mass IndexAfter completion of program (3 months)
Change from baseline Systolic Blood PressureAfter completion of program (3 months)
Change from baseline Left Ventricular Mass IndexAfter completion of program (3 months)Measured by Transthoracic Echocardiogram

Countries

Canada

Contacts

Primary ContactA. Shekhar Pandey, MD
pandey@cambridgecardiaccare.com(519) 624-3511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026