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Clinical Trials/NCT07284446
NCT07284446RecruitingNot Applicable

Prevalence of Depressive Symptoms and Cognitive Impairment and Their Association With Worse Outcomes in a Cohort of Hospitalized Patients With Chronic Heart Failure

Lithuanian University of Health Sciences1 site in 1 country300 target enrollmentStarted: December 2, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
In-hospital all-cause mortality

Study Overview

Brief Summary

The goal of this observational study is to learn about the prevalence of depressive symptoms and cognitive impairment and their association with worse outcomes in a cohort of hospitalized patients between the ages of 18 ang 85 years with chronic heart failure. The main question it aims to answer is:

• Does the presence of depressive symptoms and cognitive impairment lead to worse outcomes in a cohort of hospitalized patients with chronic heart failure? Participants who are hospitalized due to exacerbation of chronic heart failure will answer survey questions to assess their cognitive function and depressive symptoms.

Detailed Description

This is a single-centre, prospective, observational cohort study designed to evaluate the prevalence of depressive symptoms and cognitive impairment and to investigate their association with worse clinical outcomes in hospitalized patients with chronic heart failure (CHF). The study will be conducted at the Department of Cardiology and the Internal Medicine Department's Cardiology Profile of the Lithuanian University of Health Sciences Kaunas Hospital (LSMU Kaunas Hospital), Kaunas, Lithuania, where the majority of Kaunas region patients with CHF are admitted for inpatient care.

CHF is a common clinical syndrome resulting from structural and/or functional cardiac abnormalities, leading to typical symptoms, frequent hospitalizations, reduced quality of life, and high mortality. In addition to somatic burden, patients with CHF frequently experience cognitive impairment and mental health disorders, particularly anxiety and depressive disorders. These conditions are highly prevalent and are associated with poorer self-care, impaired adherence to therapy, diminished quality of life, and worse prognosis. Despite increasing recognition of their importance, depressive symptoms, anxiety, and cognitive impairment remain under-recognized and insufficiently integrated into routine CHF management. Symptom overlap between CHF and mental or cognitive disorders further complicates detection, contributing to underdiagnosis and undertreatment.

To address this gap, the present study will systematically assess depressive symptoms and cognitive function in a consecutively enrolled cohort of hospitalized patients with CHF and will examine how these factors relate to short- and medium-term outcomes.

The main objectives are:

  1. to determine the prevalence of depressive symptoms in hospitalized patients with CHF;
  2. to determine the prevalence of cognitive impairment in the same population;
  3. to evaluate the association between depressive symptoms and worse CHF outcomes;
  4. to evaluate the association between cognitive impairment and worse CHF outcomes.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patient hospitalized primarily for CHF exacerbation;
  • clinically stable, able to provide informed consent;
  • do not have severe cognitive impairment that would preclude valid questionnaire administration.

Exclusion Criteria

  • hospitalization for acute heart failure;
  • total length of hospital stay <96 hours;
  • absence of transthoracic echocardiography (TTE) within the last 12 months and no TTE planned;
  • severe visual impairment preventing completion of the visual part of the Montreal Cognitive Assessment;
  • refusal to participate.

Outcomes

Primary Outcomes

In-hospital all-cause mortality

Time Frame: From enrollment to the end of treatment up to 30 days

Lethal all-cause outcome

In-hospital MACE

Time Frame: From enrollment to the end of treatment up to 30 days

In-hospital Major Adverse Cardiovascular Event (including myocardial infarction, stroke, cardiovascular death, and need for revascularization \[like repeat PCI or bypass surgery\])

Number of Participants with chronic heart failure-related rehospitalization

Time Frame: 12 months post discharge from the hospital

Subsequent hospitalization due to chronic heart failure exacerbation (decompensation) within 12 months after the index admission to the hospital (enrollment to the study)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrius Ališauskas, MD

Principal Investigator

Lithuanian University of Health Sciences

Study Sites (1)

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