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

NCT ID: NCT05689086

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure With Reduced Ejection Fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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"

Virtual Heart Failure Optimization Program

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cambridge Cardiac Care Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

A. Pandey, MD

Role: STUDY_CHAIR

Cambridge Cardiac Care Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cambridge Cardiac Rehab

Cambridge, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

A. Shekhar Pandey, MD

Role: CONTACT

(519) 624-3511

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

A. Shekhar Pandey, BSc, MD

Role: primary

(519) 624-3511

M. Michelle Pandey, B Pharm

Role: backup

(519) 624-3511

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCCiCHF20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.