CClinicalTrials.gg
Status unknownNCT05689086Updated Jan 18, 2023

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

An observational study in Heart Failure With Reduced Ejection Fraction, sponsored by Cambridge Cardiac Care Centre. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Cambridge Cardiac Care Centre · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Heart Failure With Reduced Ejection Fraction

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

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Lead sponsor

Cambridge Cardiac Care Centre is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

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What researchers measure

Primary outcomes

  1. Change from baseline Doses of GDMT

    Beta-blocker, ACE-inhibitor/Angiotensin receptor blocker/Valsartan-Sacubitril, Mineralocorticoid Receptor Antagonist, SGLT2 inhibitor

    Time frame: After completion of program (3 months)

  2. Change from baseline Left Ventricular Ejection Fraction

    Measured in Transthoracic Echocardiogram

    Time frame: After completion of program (3 months)

Secondary outcomes

  1. Change from baseline NYHA Classification

    Stage of Heart Failure (I-IV, IV is worse)

    Time frame: After completion of program (3 months)

  2. Change from baseline Left Ventricular Mass Index

    Measured by Transthoracic Echocardiogram

    Time frame: After completion of program (3 months)

  3. Change from baseline Left Ventricular End Diastolic Diameter

    Measured by Transthoracic Echocardiogram

    Time frame: After completion of program (3 months)

  4. Change from baseline Left Ventricular End Systolic Diameter

    Measured by Transthoracic Echocardiogram

    Time frame: After completion of program (3 months)

  5. Change from baseline Serum Potassium

    Time frame: After completion of program (3 months)

  6. Change from baseline eGFR

    Time frame: After completion of program (3 months)

  7. Change from baseline Systolic Blood Pressure

    Time frame: After completion of program (3 months)

  8. Change from baseline Diastolic Blood Pressure

    Time frame: After completion of program (3 months)

  9. Change from baseline Heart Rate

    Time frame: After completion of program (3 months)

  10. Change from baseline Body Mass Index

    Time frame: After completion of program (3 months)

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05689086
Lead sponsor
Cambridge Cardiac Care Centre
Responsible party
Sponsor
First posted
Jan 18, 2023
Start date
Jan 1, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jan 18, 2023

Study contacts

A. Shekhar Pandey, MD
Contact
pandey@cambridgecardiaccare.com
(519) 624-3511
A. Pandey, MD
study chair · Cambridge Cardiac Care Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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