Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor

Heart Failure Clinical Trial

— Cog-HF  

Official title:

Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088212
• Other study ID #: P8510
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: July 2026

Study information

• Verified date: November 2023
• Source: Baker Heart and Diabetes Institute
• Contact: Quan Huynh
• Phone: 610385321833
• Email: quan.huynh[@]baker.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: July 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Cognitive Change
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Heart Failure
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• Disease management program
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MOCA score	Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better	12 months
Secondary	Change in cardiac function	Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function.	12 months
Secondary	Change in 6-minute walk distance	Functional capacity will be based on 6-minute walk test	12 and 24 months
Secondary	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	12 and 24 months
Secondary	Change in MOCA score	Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better	24 months
Secondary	Change in brain volume via MRI measurement		24 months
Secondary	Change in hand grip strength		12 and 24 months
Secondary	Change in heart failure classification	Based on New York Heart Association classification	12 and 24 months