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NCT Number: NCT06088212

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

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.

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Key information

Conditions

Heart Failure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cognition Disorders Cognitive Change Cognitive Decline Cognitive Dysfunction Cognitive Impairment Dementia Heart Diseases Left Ventricular Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menzies Institute for Medical Research

Hobart, Tasmania, 7000, Australia

Location status: Recruiting

Location contact

Kristyn Whitmore

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalised with HF as primary or secondary diagnosis.
  • At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.

Exclusion criteria

  • 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.

Treatment and study plan

Disease management program

Other

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.

Primary outcomes

  1. Change in MOCA score

    Time frame: 12 months

    Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better

Secondary outcomes

  1. Change in cardiac function

    Time frame: 12 months

    Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function.

  2. Change in 6-minute walk distance

    Time frame: 12 and 24 months

    Functional capacity will be based on 6-minute walk test

  3. Change in quality of life

    Time frame: 12 and 24 months

    Quality of life specific to heart failure symptoms will be measured using a disease-specific quality of life questionnaire: Kansas City Cardiomyopathy Questionnaire

  4. Change in MOCA score

    Time frame: 24 months

    Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better

  5. Change in brain volume via MRI measurement

    Time frame: 24 months

  6. Change in hand grip strength

    Time frame: 12 and 24 months

  7. Change in heart failure classification

    Time frame: 12 and 24 months

    Based on New York Heart Association classification

Study contacts

Contact information is provided by the study sponsor or research team.

Quan Huynh

CONTACT

[email protected]

610385321833

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Registry information

Official study title

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

Acronym: Cog-HF

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 18, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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