Depressive Symptoms, Cognitive Impairment, and Outcomes in Hospitalized Chronic Heart Failure Patients (DSCI-CHF)

December 2, 2025 updated by: Andrius Ališauskas, MD, Lithuanian University of Health Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

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.

The planned sample size is 300 patients, calculated on the basis of survival as the main clinical endpoint (mortality and CHF-related rehospitalizations), assuming an expected prevalence of depressive symptoms and cognitive impairment of approximately 10-20% among patients with CHF and a hazard ratio of 2.5 for adverse outcomes in patients with depressive symptoms and/or cognitive impairment compared with those without. Patient recruitment is anticipated to take approximately 24 months, with an additional 12 months of follow-up for clinical outcomes after the last patient is enrolled.

After clinical stabilization during the index hospitalization, eligible patients will provide written informed consent and a structured interview and baseline assessment will be performed approximately 48 hours after stabilization.

The assessment will include:

  1. collection of demographic data;
  2. physical examination;
  3. anthropometric measurements;
  4. completion of standardized, validated questionnaires for depressive symptoms and cognitive function.

Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) and the Hospital Anxiety and Depression Scale (HADS), both in validated Lithuanian versions. Cognitive function will be assessed with the Lithuanian version of the Montreal Cognitive Assessment (MoCA). All questionnaires will be administered by the principal investigator or another physician-investigator working in the study centre. The same set of questionnaires (PHQ-9, HADS, MoCA) will be repeated on the last day of the hospital stay in order to evaluate the dynamics of depressive symptoms and cognitive function during hospitalization.

In addition, routine clinical, laboratory, and instrumental data will be extracted from the paper and electronic medical records. Information on in-hospital management, including pharmacological therapy and any procedures, will also be collected.

The primary clinical outcomes of interest are:

  1. all-cause mortality during the index hospitalization;
  2. all-cause mortality after discharge;
  3. CHF-related rehospitalizations during the first 12 months after discharge from the index hospitalization.

The main exposures of interest are the presence and severity of depressive symptoms and cognitive impairment at baseline and at discharge, as defined by established cut-offs in PHQ-9, HADS, and MoCA scores.

Data will be recorded on paper case report forms and subsequently entered into a dedicated electronic database.

Statistical analyses will include descriptive statistics to characterize the prevalence and severity of depressive symptoms and cognitive impairment; univariable and multivariable regression models to examine associations between depressive symptoms and cognitive impairment and clinical and demographic characteristics; and survival analyses (Kaplan-Meier curves and Cox proportional hazards models) to evaluate the relationship between depressive symptoms, cognitive impairment, and time to death or CHF-related rehospitalization. A two-sided p value <0.05 will be considered statistically significant.

By quantifying the prevalence of depressive symptoms and cognitive impairment and clarifying their prognostic significance for patients hospitalized with CHF in Lithuania, this study aims to provide evidence to support more systematic screening, follow-up, and targeted psychosocial and cognitive interventions in this high-risk population. The findings may inform local and international clinical practice by highlighting the need to integrate mental health and cognitive assessment into comprehensive CHF management pathways.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Lithuania
      • Kaunas, Lithuania, 47144
        • Recruiting
        • Kaunas Hospital of the Lithuanian University of Health Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrius Ališauskas, MD, PhD
        • Sub-Investigator:
          • Kornelija Dzikevičiūtė, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized to the Department of Cardiology and the Internal Medicine Department's Cardiology Profile at the Lithuanian University of Health Sciences Kaunas Hospital, Kaunas, Lithuania

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CHF Group
Cohort of patients hospitalized due to Exacerbation of Chronic heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital all-cause mortality
Time Frame: From enrollment to the end of treatment up to 30 days
Lethal all-cause outcome
From enrollment to the end of treatment up to 30 days
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])
From enrollment to the end of treatment up to 30 days
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)
12 months post discharge from the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Investigators

  • Principal Investigator: Andrius Ališauskas, MD, PhD, Lithuanian University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

December 2, 2028

Study Completion (Estimated)

December 2, 2028

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEACE-pro-HF-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

1) demographic data; 2) medical history (including CHF aetiology, duration, comorbidities, prior hospitalizations, prior procedures, and current pharmacotherapy); 2) physical examination data; 3) anthropometric measurements; 4) questionnaire score data (PHQ-9, HADS, MoCA); 5) ECG data; 6) transthoracic echocardiography data; 7) chest X-ray data; 8) blood test dta (e.g., complete blood count, NT-proBNP, creatinine, urea, electrolytes, inflammatory markers, cardiac troponins); 9) information on in-hospital management, including pharmacological therapy and any procedures; 10) patient outcomes after discharge (will be ascertained through the national Electronic Health Services and Cooperation Infrastructure Information System).

IPD Sharing Time Frame

2028-11-20; 2033-11-20

IPD Sharing Access Criteria

Any researcher upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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