Heart FailureNCT07302737
Delirium and Heart Failure
An observational study of Heart Failure and Delirium Confusional State, run by Ain Shams University at 1 site in Egypt.
Trial summary
Biomarkers such as Systemic Immune-Inflammation Index (SII) and TG/Glucose Ratio (TyG) have shown promise in predicting delirium, reflecting the roles of inflammation and metabolic disturbances in its pathophysiology. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Delirium Confusional State
- What is being tested?
- Comprehensive Geriatric Assessment, the Confusion Assessment Method (CAM test) or CAM-ICU and Delirium Rating Scale - Revised-98
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2026to 1 Aug 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hospitalized older adults with heart failure
Who may be able to join
- Heart failure stage C
Who cannot join
- cognitive impairment
- Major Neurological Conditions: (e.g., stroke, traumatic brain injury).
- Hematological diseases that affect platelet, neutrophil, and lymphocyte counts.
- Cardiogenic Shock
- Sepsis
- Ongoing Treatment with Immunosuppressants, or corticosteroids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University hospitals
Cairo, 11566
Doha Rasheedy, Professor, 0201001193544, doharasheedy@med.asu.edu.eg
About this study
Official title: Accuracy of Different Biomarkers for Predicting Delirium in Older Adults With Heart Failure
Biomarkers such as Systemic Immune-Inflammation Index (SII) and TG/Glucose Ratio (TyG) have shown promise in predicting delirium, reflecting the roles of inflammation and metabolic disturbances in its pathophysiology. This study aims to compare the predictive value of SII and the TyG ratio among other chemical and physiological biomarkers for diagnosing delirium and detecting its severity in older adults with heart failure. These biomarkers reflect different pathophysiological pathways implicated in delirium, including inflammation, cardiovascular stress, and metabolic dysfunction. By evaluating their individual and combined predictive abilities, this research seeks to identify potential tools for early identification of patients at high risk for delirium
- Conditions
- Heart Failure, Delirium Confusional State
- Being tested
- Comprehensive Geriatric Assessment, the Confusion Assessment Method (CAM test) or CAM-ICU, Delirium Rating Scale - Revised-98, blood biomarkers
- Keywords
- Heart failure, delirium, older adults
- Medical subject headings
- Heart Failure, Confusion, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
multidimensional assessment of cognition, physical, function, mood, social status of the participants
the Confusion Assessment Method (CAM test) or CAM-ICUOther
standardized tool designed to quickly and accurately diagnose delirium by assessing four key features: acute mental change, inattention, and either disorganized thinking or altered consciousness. The original CAM is used for communicative patients on general wards, relying on conversation, while the CAM-ICU is adapted for critically ill, often non-verbal patients in the ICU, using non-verbal tasks and sedation scales. By providing a rapid, reliable method for identifying this often-missed condition, both tools trigger crucial medical interventions, helping to mitigate delirium's serious risks, including longer hospital stays, long-term cognitive decline, and increased mortality.
Delirium Rating Scale - Revised-98Other
The Delirium Rating Scale-Revised-98 (DRS-R-98) is a standardized, expert-rated clinical tool designed specifically to measure the severity of delirium and help distinguish it from other psychiatric disorders, such as dementia, depression, and schizophrenia. Unlike the CAM/CAM-ICU, which provides a simple "yes/no" diagnosis, the DRS-R-98 quantifies how severe a patient's delirium is at a given point in time and tracks changes in that severity over the course of the illness
blood biomarkersDiagnostic test
complete blood count(to obtain systemic inflammatory index) ,triglyceride (TG) and glucose, Liver and kidney function tests and serum electrolytes level
| Study group | Role | What they receive |
|---|---|---|
| cases | hospitalized older patients with heart failure and delirium Receives: Other: Comprehensive Geriatric Assessment; Other: the Confusion Assessment Method (CAM test) or CAM-ICU; Other: Delirium Rating Scale - Revised-98; Diagnostic Test: blood biomarkers | |
| controls | age and gender matched heart failure older patients without delirium Receives: Other: Comprehensive Geriatric Assessment; Other: the Confusion Assessment Method (CAM test) or CAM-ICU; Diagnostic Test: blood biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity and specificity of different biomarkers of delirium in heart failure older patient
assess sensitivity and specificity of the systemic inflammatory index (SII), Rate Pressure Product (RPP), and TG/glucose ratio in predicting delirium
Measured: Within 24 hours of hospital admission
Secondary outcomes (2)
in hospital morbidity
follow up cohort for possible complications like acute kidney injury, infections, or adverse drug events
Measured: From enrollment to the hospital discharge about 6 weeks
In hospital mortality
cohort follow up throughout hospital course and mortality recorded
Measured: From enrollment to hospital discharge about 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302737
- Sponsor's protocol ID
- FMASU MD195/2025
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Different Biomarkers for Predicting Delirium in Older Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT07302737
- Acronym / sponsor ID
- FMASU MD195/2025
- Conditions
- Heart Failure, Delirium Confusional State
- Keywords
- Heart failure, delirium, older adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 24 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.
Biomarkers such as Systemic Immune-Inflammation Index (SII) and TG/Glucose Ratio (TyG) have shown promise in predicting delirium, reflecting the roles of inflammation and metabolic disturbances in its pathophysiology. This study aims to compare the predictive value of SII and the TyG ratio among other chemical and physiological biomarkers for diagnosing delirium and detecting its severity in older adults with heart failure. These biomarkers reflect different pathophysiological pathways implicated in delirium, including inflammation, cardiovascular stress, and metabolic dysfunction. By evaluating their individual and combined predictive abilities, this research seeks to identify potential tools for early identification of patients at high risk for delirium
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: Comprehensive Geriatric Assessment, Other: the Confusion Assessment Method (CAM test) or CAM-ICU, Other: Delirium Rating Scale - Revised-98, Diagnostic Test: blood biomarkershospitalized older patients with heart failure and delirium |
| controls | – | Other: Comprehensive Geriatric Assessment, Other: the Confusion Assessment Method (CAM test) or CAM-ICU, Diagnostic Test: blood biomarkersage and gender matched heart failure older patients without delirium |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized older adults with heart failure
Key inclusion criteria (1 listed)
- Heart failure stage C
Key exclusion criteria (6 listed)
- cognitive impairment
- Major Neurological Conditions: (e.g., stroke, traumatic brain injury).
- Hematological diseases that affect platelet, neutrophil, and lymphocyte counts.
- Cardiogenic Shock
- Sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric Assessmentmultidimensional assessment of cognition, physical, function, mood, social status of the participants | Other | cases, controls |
| the Confusion Assessment Method (CAM test) or CAM-ICUstandardized tool designed to quickly and accurately diagnose delirium by assessing four key features: acute mental change, inattention, and either disorganized thinking or altered consciousness. The original CAM is used for communicative patients on general wards, relying on conversation, while the CAM-ICU is adapted for critically ill, often non-verbal patients in the ICU, using non-verbal tasks and sedation scales. By providing a rapid, reliable method for identifying this often-missed condition, both tools trigger crucial medical interventions, helping to mitigate delirium's serious risks, including longer hospital stays, long-term cognitive decline, and increased mortality. | Other | cases, controls |
| Delirium Rating Scale - Revised-98The Delirium Rating Scale-Revised-98 (DRS-R-98) is a standardized, expert-rated clinical tool designed specifically to measure the severity of delirium and help distinguish it from other psychiatric disorders, such as dementia, depression, and schizophrenia. Unlike the CAM/CAM-ICU, which provides a simple "yes/no" diagnosis, the DRS-R-98 quantifies how severe a patient's delirium is at a given point in time and tracks changes in that severity over the course of the illness | Other | cases |
| blood biomarkerscomplete blood count(to obtain systemic inflammatory index) ,triglyceride (TG) and glucose, Liver and kidney function tests and serum electrolytes level | Diagnostic test | cases, controls |
Primary outcome
the sensitivity and specificity of different biomarkers of delirium in heart failure older patient
Time frame: Within 24 hours of hospital admission
assess sensitivity and specificity of the systemic inflammatory index (SII), Rate Pressure Product (RPP), and TG/glucose ratio in predicting delirium
2 secondary outcomes
in hospital morbidity
Time frame: From enrollment to the hospital discharge about 6 weeks
In hospital mortality
Time frame: From enrollment to hospital discharge about 6 weeks
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 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Heart Failure and Delirium Confusional State, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensitivity and specificity of different biomarkers of delirium in heart failure older patient (time frame: Within 24 hours of hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.