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

JRCT ID: jRCT1030230386

Registered date:07/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure
• Date of first enrollment: 07/10/2023
• Target sample size: 220
• Study type: Interventional
• Intervention(s): The study will perform a comprehensive disease management program for eligible patients in the intervention arm. This comprehensive disease management program will consist of fluid assessment with pocket echocardiography, optimization of heart failure medications according to the guidelines, intensive heart failure education, outpatient or telephone monitoring of heart failure management, and education for home exercise therapy. No drugs, medical devices, or medical supplies is used beyond insurance coverage.

Outcome(s)

• Primary Outcome: Change in MoCA-J from baseline to 12 months after intervention

Secondary Outcome

Change in Hippocampal Volume from baseline to 12 months after intervention
Change in cerebral white matter lesions from baseline to 12 months after intervention
Change in cerebral gray matter volume from baseline to 12 Months after intervention
Change in KCCQ-12 from baseline to 12 months after intervention
Change in NT-proBNP from baseline to 12 months after intervention
Change in E/e' from baseline to 12 months after iIntervention
Change in left atrial volume from baseline to 12 months after intervention

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients equal or more than 50 years age
2) Patients with heart failure
3) Patients with a baseline MoCA-J score < 26 (regardless of the cause of dementia)
4) Patients who have given written informed consent to participate in the study

Exclude criteria

1) Patients with severe dementia for whom MoCA-J is difficult to perform
2) Patients who require palliative care
3) Patients with comorbidities for which a prognosis of at least 1 year is not expected (other than heart failure)
4) Patients participating in other interventional trials
5) Other patients who are judged by the physician to be inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Obokata Masaru