Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor (Cog-HF)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cognitive Impairment; Dementia; Cognitive Change; Cognitive Decline; Left Ventricular Dysfunction
• Intervention / Treatment: Other: Disease management program

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quan Huynh; Phone Number: 610385321833; Email: quan.huynh@baker.edu.au

Study Locations

• Australia
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Menzies Institute for Medical Research
      • Contact: Kristyn Whitmore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MOCA score	Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in 6-minute walk distance	Functional capacity will be based on 6-minute walk test	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	12 and 24 months
Change in MOCA score	Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better	24 months
Change in brain volume via MRI measurement		24 months
Change in hand grip strength		12 and 24 months
Change in heart failure classification	Based on New York Heart Association classification	12 and 24 months

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute
• Investigators: Principal Investigator: Thomas H Marwick, MBBS PhD MPH, Baker Heart and Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Cognition Disorders; Heart Failure; Cognitive Dysfunction; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: P8510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No