Heart FailureCog-HFNCT06088212
Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor
A study testing Disease management program in people with Heart Failure and Cognitive Impairment, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial summary
This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cognitive Impairment, Dementia
- What is being tested?
- Disease management program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2024to Jul 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalised with HF as primary or secondary diagnosis.
- At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.
Who cannot join
- Unable to provide written consent; requiring palliative care; or participating in another RCT
- Recovery of cognitive function shortly after hospital discharge: to ensure that we only include patients with "true" CI, any patients with a repeated MoCA>25 at 2 weeks post-discharge will be excluded.
- Terminal illness (eg. cancer) that may influence 12-month prognosis.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Menzies Institute for Medical Research
Hobart, Tasmania, 7000
Kristyn Whitmore
About this study
Official title: Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial
This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and implementation. Findings from this research will transform the way healthcare is delivered to cognitively impaired patients with heart disease who have a very high risk of developing dementia.
- Conditions
- Heart Failure, Cognitive Impairment, Dementia, Left Ventricular Dysfunction, Cognitive Change, Cognitive Decline
- Being tested
- Disease management program
- Medical subject headings
- Heart Failure, Cognitive Dysfunction, Dementia, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease management programOther
The components of our DMP include:
- Intensive post-discharge education
- Home surveillance of signs and symptoms will be reviewed (weekly in the first month and monthly thereafter) in a telehealth consultation with patient and/or carer.
- Medical treatment involves a planned up-titration of cardioprotective medications that will proceed in the absence of advice from the general practitioner (GP) to the contrary. Close observation and frequent appointments are organised by the nurse with the patient's GP during up-titration period.
- Exercise program delivered by an exercise physiologist
- Maintenance phase of the DMP: During this maintenance phase, Intervention patients should have been fully transitioned to home care where they are managed by their GP at optimal doses of their medications. Repeated education and exercise guidance will continue with the carer, supported by our cardiac nurse and exercise physiologist via telehealth consultation bimonthly.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care patients will continue with the hospital follow-up plan and routine preventive care after hospital discharge. |
| Intervention | Experimental | Intervention patients will receive a disease management program in addition to the usual care. Receives: Other: Disease management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MOCA score
Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
Measured: 12 months
Secondary outcomes (7)
Change in cardiac function
Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function.
Measured: 12 months
Change in 6-minute walk distance
Functional capacity will be based on 6-minute walk test
Measured: 12 and 24 months
Change in quality of life
Quality of life specific to heart failure symptoms will be measured using a disease-specific quality of life questionnaire: Kansas City Cardiomyopathy Questionnaire
Measured: 12 and 24 months
Change in MOCA score
Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
Measured: 24 months
Change in brain volume via MRI measurement
Measured: 24 months
Change in hand grip strength
Measured: 12 and 24 months
Change in heart failure classification
Based on New York Heart Association classification
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas H Marwick, MBBS PhD MPH, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088212
- Sponsor's protocol ID
- P8510
- Acronym
- Cog-HF
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2023
- Last updated
- 12 Aug 2024
- Results posted
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial
- ClinicalTrials.gov ID
- NCT06088212
- Acronym / sponsor ID
- Cog-HF / P8510
- Conditions
- Heart Failure, Cognitive Impairment, Dementia, Left Ventricular Dysfunction, Cognitive Change, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Oct 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.
This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and implementation. Findings from this research will transform the way healthcare is delivered to cognitively impaired patients with heart disease who have a very high risk of developing dementia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care patients will continue with the hospital follow-up plan and routine preventive care after hospital discharge. |
| Intervention | Experimental | Other: Disease management programIntervention patients will receive a disease management program in addition to the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalised with HF as primary or secondary diagnosis.
- At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.
Key exclusion criteria (3 listed)
- Unable to provide written consent; requiring palliative care; or participating in another RCT
- Recovery of cognitive function shortly after hospital discharge: to ensure that we only include patients with "true" CI, any patients with a repeated MoCA>25 at 2 weeks post-discharge will be excluded.
- Terminal illness (eg. cancer) that may influence 12-month prognosis.
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 |
|---|---|---|
| Disease management programThe components of our DMP include: 1. Intensive post-discharge education 2. Home surveillance of signs and symptoms will be reviewed (weekly in the first month and monthly thereafter) in a telehealth consultation with patient and/or carer. 3. Medical treatment involves a planned up-titration of cardioprotective medications that will proceed in the absence of advice from the general practitioner (GP) to the contrary. Close observation and frequent appointments are organised by the nurse with the patient's GP during up-titration period. 4. Exercise program delivered by an exercise physiologist 5. Maintenance phase of the DMP: During this maintenance phase, Intervention patients should have been fully transitioned to home care where they are managed by their GP at optimal doses of their medications. Repeated education and exercise guidance will continue with the carer, supported by our cardiac nurse and exercise physiologist via telehealth consultation bimonthly. | Other | Intervention |
Primary outcome
Change in MOCA score
Time frame: 12 months
Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
7 secondary outcomes
Change in cardiac function
Time frame: 12 months
Change in 6-minute walk distance
Time frame: 12 and 24 months
Change in quality of life
Time frame: 12 and 24 months
Change in MOCA score
Time frame: 24 months
Change in brain volume via MRI measurement
Time frame: 24 months
Change in hand grip strength
Time frame: 12 and 24 months
Change in heart failure classification
Time frame: 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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.
Thomas H Marwick, MBBS PhD MPH principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease management program in people with Heart Failure and Cognitive Impairment, run by Baker Heart and Diabetes Institute at 1 site in Australia.
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 3 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 12 Aug 2024. 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 Australia. 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 Quan Huynh (610385321833, quan.huynh@baker.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MOCA score (time frame: 12 months). 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 12 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.