Heart Failure With Reduced Ejection FractionNCT05689086
A Virtual Heart Failure Optimization Program for Guideline Directed Medical Therapy and Cardiac Rehabilitation
An observational study of Heart Failure With Reduced Ejection Fraction, run by Cambridge Cardiac Care Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Virtual Heart Failure Optimization Program
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with HFrEF (ejection fraction less than 40%) with New York Heart Association (NYHA) class II or III symptoms
Who may be able to join
- 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
Who cannot join
- Patients who are pregnant
- Patients who who are incarcerated
- Cardiac Transplant Patients
- Patients with Left Ventricular Assist Devices
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cambridge Cardiac Rehab
Cambridge, Ontario, N1R 6V6
A. Shekhar Pandey, BSc, MD, (519) 624-3511, pandey@cambridgecardiaccare.com
M. Michelle Pandey, B Pharm, (519) 624-3511, michellepandey@cambridgecardiaccare.com
About this study
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.
- Being tested
- Virtual Heart Failure Optimization Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Heart Failure Optimization ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: Other: Virtual Heart Failure Optimization Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Doses of GDMT
Beta-blocker, ACE-inhibitor/Angiotensin receptor blocker/Valsartan-Sacubitril, Mineralocorticoid Receptor Antagonist, SGLT2 inhibitor
Measured: After completion of program (3 months)
Change from baseline Left Ventricular Ejection Fraction
Measured in Transthoracic Echocardiogram
Measured: After completion of program (3 months)
Secondary outcomes (10)
Change from baseline NYHA Classification
Stage of Heart Failure (I-IV, IV is worse)
Measured: After completion of program (3 months)
Change from baseline Left Ventricular Mass Index
Measured by Transthoracic Echocardiogram
Measured: After completion of program (3 months)
Change from baseline Left Ventricular End Diastolic Diameter
Measured by Transthoracic Echocardiogram
Measured: After completion of program (3 months)
Change from baseline Left Ventricular End Systolic Diameter
Measured by Transthoracic Echocardiogram
Measured: After completion of program (3 months)
Change from baseline Serum Potassium
Measured: After completion of program (3 months)
Change from baseline eGFR
Measured: After completion of program (3 months)
Change from baseline Systolic Blood Pressure
Measured: After completion of program (3 months)
Change from baseline Diastolic Blood Pressure
Measured: After completion of program (3 months)
Change from baseline Heart Rate
Measured: After completion of program (3 months)
Change from baseline Body Mass Index
Measured: After completion of program (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Cardiac Care Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. Pandey, MD, Study chair, Cambridge Cardiac Care Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689086
- Sponsor's protocol ID
- CCCiCHF20
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Heart Failure Optimization Program for Guideline Directed Medical Therapy and Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05689086
- Acronym / sponsor ID
- CCCiCHF20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cambridge Cardiac Care CentreUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Program Participants | – | Other: Virtual Heart Failure Optimization ProgramPatients with HFrEF (LVEF<40%) \& NYHA class II-III who are referred to and consent to participate in the "Virtual Heart Failure Optimization Program" |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with HFrEF (ejection fraction less than 40%) with New York Heart Association (NYHA) class II or III symptoms
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Patients who are pregnant
- Patients who who are incarcerated
- Cardiac Transplant Patients
- Patients with Left Ventricular Assist Devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Heart Failure Optimization ProgramParticipants 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. | Other | Program Participants |
Primary outcome
Change from baseline Doses of GDMT
Time frame: After completion of program (3 months)
Beta-blocker, ACE-inhibitor/Angiotensin receptor blocker/Valsartan-Sacubitril, Mineralocorticoid Receptor Antagonist, SGLT2 inhibitor
Change from baseline Left Ventricular Ejection Fraction
Time frame: After completion of program (3 months)
Measured in Transthoracic Echocardiogram
10 secondary outcomes
Change from baseline NYHA Classification
Time frame: After completion of program (3 months)
Change from baseline Left Ventricular Mass Index
Time frame: After completion of program (3 months)
Change from baseline Left Ventricular End Diastolic Diameter
Time frame: After completion of program (3 months)
Change from baseline Left Ventricular End Systolic Diameter
Time frame: After completion of program (3 months)
Change from baseline Serum Potassium
Time frame: After completion of program (3 months)
Change from baseline eGFR
Time frame: After completion of program (3 months)
Change from baseline Systolic Blood Pressure
Time frame: After completion of program (3 months)
Change from baseline Diastolic Blood Pressure
Time frame: After completion of program (3 months)
Change from baseline Heart Rate
Time frame: After completion of program (3 months)
Change from baseline Body Mass Index
Time frame: After completion of program (3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Pandey, MD study chair
Cambridge Cardiac Care Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by Cambridge Cardiac Care Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A. Shekhar Pandey, MD ((519) 624-3511, pandey@cambridgecardiaccare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Doses of GDMT (time frame: After completion of program (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.