Congestive Heart Failure ChronicDSCI-CHFNCT07284446
Depressive Symptoms, Cognitive Impairment, and Outcomes in Hospitalized Chronic Heart Failure Patients
An observational study of Congestive Heart Failure Chronic and Cognitive Impairment, Mild, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure Chronic, Cognitive Impairment, Mild, Depressive Symptoms Mild to Moderate in Severity
- How many people
- 300 participants
- Where
- 1 siteLithuania
- Study dates
- 2 Dec 2025to 2 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Kaunas Hospital of the Lithuanian University of Health Sciences
Kaunas, 47144
Andrius Ališauskas, MD, PhD, +37060379771, andrius.alisauskas@lsmu.lt
Kornelija Dzikevičiūtė, MD, +37061875828, kornelija.dzikeviciute@stud.lasmu.lt
About this study
Official title: 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.
Read the 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:
- to determine the prevalence of depressive symptoms in hospitalized patients with CHF;
- to determine the prevalence of cognitive impairment in the same population;
- to evaluate the association between depressive symptoms and worse CHF outcomes;
- 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:
- collection of demographic data;
- physical examination;
- anthropometric measurements;
- 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:
- all-cause mortality during the index hospitalization;
- all-cause mortality after discharge;
- 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.
- 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
- Medical subject headings
- Cognitive Dysfunction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHF Group | Cohort of patients hospitalized due to Exacerbation of Chronic heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital all-cause mortality
Lethal all-cause outcome
Measured: 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])
Measured: 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)
Measured: 12 months post discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start2 Dec 2025
- Primary completion2 Dec 2028 (estimated)
- Study completion2 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrius Ališauskas, MD, Lithuanian University of Health Sciences
- Investigators
- Andrius Ališauskas, MD, PhD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284446
- Sponsor's protocol ID
- PEACE-pro-HF-1
- Acronym
- DSCI-CHF
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 39327721Alisauskas 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.
PubMed 36564931Sadauskas 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.
PubMed 30227444Trends 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.
PubMed 31594775Jones 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.
PubMed 31523902Celano 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.
PubMed 29975336Li 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.
PubMed 38084332Reina-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.
PubMed 34707513Celano 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.
PubMed 27671918Moradi 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.
PubMed 34006389Chouairi 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.
PubMed 34166799Polikandrioti 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.
PubMed 25701969Di Palo KE. Psychological Disorders in Heart Failure. Cardiol Clin. 2022 May;40(2):269-276. doi: 10.1016/j.ccl.2021.12.014.
PubMed 35465900Savarese 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.
PubMed 35150240Rees 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.
PubMed 37775162
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Depressive Symptoms and Cognitive Impairment and Their Association With Worse Outcomes in a Cohort of Hospitalized Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT07284446
- Acronym / sponsor ID
- DSCI-CHF / PEACE-pro-HF-1
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 2 Dec 2028 (estimated)
- Study completion
- 2 Dec 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to determine the prevalence of depressive symptoms in hospitalized patients with CHF;
- to determine the prevalence of cognitive impairment in the same population;
- to evaluate the association between depressive symptoms and worse CHF outcomes;
- 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:
- collection of demographic data;
- physical examination;
- anthropometric measurements;
- 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:
- all-cause mortality during the index hospitalization;
- all-cause mortality after discharge;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHF Group | – | –Cohort of patients hospitalized due to Exacerbation of Chronic heart failure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 39327721Alisauskas 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.
- Background: PubMed 36564931Alisauskas 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.
- Background: PubMed 30227444Sadauskas 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.
- Background: PubMed 31594775Trends 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.
- Background: PubMed 31523902Jones 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.
- Background: PubMed 29975336Celano 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.
- Background: PubMed 38084332Li 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.
- Background: PubMed 34707513Reina-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.
- Background: PubMed 27671918Celano 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.
- Background: PubMed 34006389Moradi 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.
- Background: PubMed 34166799Chouairi 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.
- Background: PubMed 25701969Polikandrioti 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrius Ališauskas, MD, PhD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure Chronic and Cognitive Impairment, Mild, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrius Ališauskas, MD, PhD (+37060379771, andrius.alisauskas@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital all-cause mortality (time frame: From enrollment to the end of treatment up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07284446, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.