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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06088212




Registration number
NCT06088212
Ethics application status
Date submitted
27/09/2023
Date registered
18/10/2023

Titles & IDs
Public title
Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor
Scientific title
Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial
Secondary ID [1] 0 0
P8510
Universal Trial Number (UTN)
Trial acronym
Cog-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Cognitive Impairment 0 0
Dementia 0 0
Left Ventricular Dysfunction 0 0
Cognitive Change 0 0
Cognitive Decline 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Disease management program

No intervention: Usual care - Usual care patients will continue with the hospital follow-up plan and routine preventive care after hospital discharge.

Experimental: Intervention - Intervention patients will receive a disease management program in addition to the usual care.


Other interventions: Disease management program
The 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in MOCA score
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Change in cardiac function
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Change in 6-minute walk distance
Timepoint [2] 0 0
12 and 24 months
Secondary outcome [3] 0 0
Change in quality of life
Timepoint [3] 0 0
12 and 24 months
Secondary outcome [4] 0 0
Change in MOCA score
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Change in brain volume via MRI measurement
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Change in hand grip strength
Timepoint [6] 0 0
12 and 24 months
Secondary outcome [7] 0 0
Change in heart failure classification
Timepoint [7] 0 0
12 and 24 months

Eligibility
Key inclusion criteria
1. Hospitalised with HF as primary or secondary diagnosis.
2. At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide written consent; requiring palliative care; or participating in another RCT
2. 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.
3. Terminal illness (eg. cancer) that may influence 12-month prognosis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Menzies Institute for Medical Research - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas H Marwick, MBBS PhD MPH
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Quan Huynh
Address 0 0
Country 0 0
Phone 0 0
610385321833
Fax 0 0
Email 0 0
quan.huynh@baker.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06088212