Depressive Symptoms, Cognitive Impairment, and Outcomes in Hospitalized Chronic Heart Failure Patients

NCT07284446 | Recruiting

• 1 other identifier: PEACE-pro-HF-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure Chronic; Cognitive Impairment, Mild; Depressive Symptoms Mild to Moderate in Severity

Keywords

Congestive Heart Failure; Mild Cognitive Impairment; Long-term Outcomes; Mild Depressive Symptoms; Rehospitalizations

Outcome Measures

Primary Outcomes (3)

• In-hospital all-cause mortality

  Lethal all-cause outcome

  From enrollment to the end of treatment up to 30 days

• In-hospital MACE

  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

  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

Study Arms (1)

CHF Group

Cohort of patients hospitalized due to Exacerbation of Chronic heart failure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Kaunas Hospital of the Lithuanian University of Health Sciences

Kaunas, 47144, Lithuania

RECRUITING

Related Publications (15)

• Alisauskas A, Dzikeviciute K, Rimsaite U, Naudziunas A, Razvadauskas H, Zinkiene D, Repecka T, Jucevicius J, Sadauskas S. Prognostic Value of Transthoracic Impedance Cardiography, Amino-Terminal Pro-B-Type Natriuretic Peptide Levels, The Six-Minute Walk Test, and Chest X-Ray in Elderly Patients with Chronic Heart Failure: A Comparative Study in Lithuania. Med Sci Monit. 2024 Sep 27;30:e945647. doi: 10.12659/MSM.945647.

  PMID: 39327721 BACKGROUND

• Alisauskas A, Naudziunas A, Sadauskas S, Jankauskiene L, Kalinauskiene E, Vanagaite G. Single-Center Study in Lithuania to Evaluate the Role of Transthoracic Impedance Cardiography in the Diagnosis and Outcome Evaluation of 301 Patients with Chronic Heart Failure Exacerbation. Med Sci Monit. 2022 Dec 24;28:e938389. doi: 10.12659/MSM.938389.

  PMID: 36564931 BACKGROUND

• Sadauskas S, Naudziunas A, Unikauskas A, Masanauskiene E, Alisauskas A, Baksyte G, Macas A. Diagnostic and Outcome Prediction Value of Transthoracic Impedance Cardiography in Heart Failure Patients During Heart Failure Flare-Ups. Med Sci Monit. 2018 Sep 18;24:6573-6578. doi: 10.12659/MSM.910754.

  PMID: 30227444 BACKGROUND

• Trends in survival after a diagnosis of heart failure in the United Kingdom 2000-2017: population based cohort study. BMJ. 2019 Oct 8;367:l5840. doi: 10.1136/bmj.l5840. No abstract available.

  PMID: 31594775 BACKGROUND

• Jones NR, Roalfe AK, Adoki I, Hobbs FDR, Taylor CJ. Survival of patients with chronic heart failure in the community: a systematic review and meta-analysis. Eur J Heart Fail. 2019 Nov;21(11):1306-1325. doi: 10.1002/ejhf.1594. Epub 2019 Sep 16.

  PMID: 31523902 BACKGROUND

• Celano CM, Villegas AC, Albanese AM, Gaggin HK, Huffman JC. Depression and Anxiety in Heart Failure: A Review. Harv Rev Psychiatry. 2018 Jul/Aug;26(4):175-184. doi: 10.1097/HRP.0000000000000162.

  PMID: 29975336 BACKGROUND

• Li X, Zhou J, Wang M, Yang C, Sun G. Cardiovascular disease and depression: a narrative review. Front Cardiovasc Med. 2023 Nov 21;10:1274595. doi: 10.3389/fcvm.2023.1274595. eCollection 2023.

  PMID: 38084332 BACKGROUND

• Reina-Couto M, Pereira-Terra P, Quelhas-Santos J, Silva-Pereira C, Albino-Teixeira A, Sousa T. Inflammation in Human Heart Failure: Major Mediators and Therapeutic Targets. Front Physiol. 2021 Oct 11;12:746494. doi: 10.3389/fphys.2021.746494. eCollection 2021.

  PMID: 34707513 BACKGROUND

• Celano CM, Daunis DJ, Lokko HN, Campbell KA, Huffman JC. Anxiety Disorders and Cardiovascular Disease. Curr Psychiatry Rep. 2016 Nov;18(11):101. doi: 10.1007/s11920-016-0739-5.

  PMID: 27671918 BACKGROUND

• Moradi M, Doostkami M, Behnamfar N, Rafiemanesh H, Behzadmehr R. Global Prevalence of Depression among Heart Failure Patients: A Systematic Review and Meta-Analysis. Curr Probl Cardiol. 2022 Jun;47(6):100848. doi: 10.1016/j.cpcardiol.2021.100848. Epub 2021 Mar 30.

  PMID: 34006389 BACKGROUND

• Chouairi F, Fuery MA, Mullan CW, Caraballo C, Sen S, Maulion C, Wilkinson ST, Surti T, McCullough M, Miller PE, Pacor J, Leifer ES, Felker GM, Velazquez EJ, Fiuzat M, O'Connor CM, Januzzi JL, Desai NR, Ahmad T. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial. J Card Fail. 2021 Dec;27(12):1359-1366. doi: 10.1016/j.cardfail.2021.06.008. Epub 2021 Jun 22.

  PMID: 34166799 BACKGROUND

• Polikandrioti M, Goudevenos J, Michalis LK, Koutelekos J, Kyristi H, Tzialas D, Elisaf M. Factors associated with depression and anxiety of hospitalized patients with heart failure. Hellenic J Cardiol. 2015 Jan-Feb;56(1):26-35.

  PMID: 25701969 BACKGROUND

• Di Palo KE. Psychological Disorders in Heart Failure. Cardiol Clin. 2022 May;40(2):269-276. doi: 10.1016/j.ccl.2021.12.014.

  PMID: 35465900 BACKGROUND

• Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.

  PMID: 35150240 BACKGROUND

• Rees OL, Wheen P, Anderson LJ. Updates in heart failure. Clin Med (Lond). 2023 Sep;23(5):432-436. doi: 10.7861/clinmed.2023-2023-23.5.Cardio1.

  PMID: 37775162 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Heart Failure

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrius Ališauskas, MD, PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrius Ališauskas, MD, PhD

CONTACT

+37060379771; andrius.alisauskas@lsmu.lt

Kornelija Dzikevičiūtė, MD

CONTACT

+37061875828; kornelija.dzikeviciute@stud.lsmu.lt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 16, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 2, 2028
• Study Completion (Estimated): December 2, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2028-11-20; 2033-11-20
• Access Criteria: Any researcher upon reasonable request

Locations

LI (1)