Acute Heart FailureNCT06491628
Liver Function Abnormalities in Patients With Acute Heart Failure
An observational study of Acute Heart Failure, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Avoiding the risk factors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Adult, Older adult
Study population: patients aged 18 yrs or older presenting with AHF
Who may be able to join
- patients aged 18 yrs or older presenting with AHF
Who cannot join
- Congenital heart disease
- acute and chronic liver diseases
Trial locations and contacts
1 site in 1 country.
Hassan Ahmed contact
About this study
Official title: Liver Function Abnormalities in Patients With Acute Heart Failure in Sohag University Hospitals
The aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients
Read the detailed description
Cardiac failure has a negative impact on the function of all parenchymatous organs, based both on the low organ perfusion in the left-sided failure and on the venous congestion in the right-sided failure.
The pathophysiology of acute heart failure (AHF) is complex and not fully understood. It has been hypothesized that an episode of acute decompensation affects not only the cardiovascular system itself, but may also deteriorate the function of other organs, c ausing serious clinical consequences. Liver involvement has been mostly described and investigated in patients with chronic HF.
Liver enzyme alterations are usually classified as relating predominantly to liver cell necrosis (signified by transaminase elevations) or predominantly to cholestasis (signified by elevated alkaline phosphatase (AP) level).
- Conditions
- Acute Heart Failure
- Being tested
- Avoiding the risk factors
- Keywords
- LFTs, AHF
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avoiding the risk factorsBehavioural
Exercise, Salt and lipid reduction in diet, smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Acute decompensated heart failure (de novo or as decompensation of chronic heart failure) | This umbrella term includes patients presenting forthe first time with typical symptoms and signs of heart failure(de novo AHF) and also those with worsening of their pre-existing cardiomyopathy (acute decompensated heart failure). Receives: Behavioral: Avoiding the risk factors | |
| Pulmonary edema | It's the real clinical presentation of AHF, typically, signs and symptoms develope rapidly and patients demonstrate severe respiratory distress with tachypnea, orthopnea and pulmonary congestion Receives: Behavioral: Avoiding the risk factors | |
| Hypertensive acute heart failure | the condition is associated with elevated blood pressure with accompanying dyspnea. orthopnea and pulmonary congestion, often in patients with relatively preserved left ventricle ejection fraction Receives: Behavioral: Avoiding the risk factors | |
| cardiogenic shock | severe peripheral hypoperfusion wih subsequent end organs damage,typically it's associated with low blood pressure and low urine output Receives: Behavioral: Avoiding the risk factors | |
| Acute coronary syndrome complicated by heart failure | characterized by complex structural, hemodynamic and neurohormonal interaction need urgent referral for coronary intervention poor outcome Receives: Behavioral: Avoiding the risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals
assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF
Measured: baseline
Secondary outcomes (1)
Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals
assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Saber, Sohag University
- Investigators
- Hamdy Saad, Study chair, Sohag UniversityHaitham Mohammad, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491628
- Sponsor's protocol ID
- LFTs abnormalities in AHF
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Function Abnormalities in Patients With Acute Heart Failure in Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06491628
- Acronym / sponsor ID
- LFTs abnormalities in AHF
- Conditions
- Acute Heart Failure
- Keywords
- LFTs, AHF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Jul 2024 (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 aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients
Detailed description
Cardiac failure has a negative impact on the function of all parenchymatous organs, based both on the low organ perfusion in the left-sided failure and on the venous congestion in the right-sided failure.
The pathophysiology of acute heart failure (AHF) is complex and not fully understood. It has been hypothesized that an episode of acute decompensation affects not only the cardiovascular system itself, but may also deteriorate the function of other organs, c ausing serious clinical consequences. Liver involvement has been mostly described and investigated in patients with chronic HF.
Liver enzyme alterations are usually classified as relating predominantly to liver cell necrosis (signified by transaminase elevations) or predominantly to cholestasis (signified by elevated alkaline phosphatase (AP) level).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acute decompensated heart failure (de novo or as decompensation of chronic heart failure) | – | Behavioral: Avoiding the risk factorsThis umbrella term includes patients presenting forthe first time with typical symptoms and signs of heart failure(de novo AHF) and also those with worsening of their pre-existing cardiomyopathy (acute decompensated heart failure). |
| Pulmonary edema | – | Behavioral: Avoiding the risk factorsIt's the real clinical presentation of AHF, typically, signs and symptoms develope rapidly and patients demonstrate severe respiratory distress with tachypnea, orthopnea and pulmonary congestion |
| Hypertensive acute heart failure | – | Behavioral: Avoiding the risk factorsthe condition is associated with elevated blood pressure with accompanying dyspnea. orthopnea and pulmonary congestion, often in patients with relatively preserved left ventricle ejection fraction |
| cardiogenic shock | – | Behavioral: Avoiding the risk factorssevere peripheral hypoperfusion wih subsequent end organs damage,typically it's associated with low blood pressure and low urine output |
| Acute coronary syndrome complicated by heart failure | – | Behavioral: Avoiding the risk factorscharacterized by complex structural, hemodynamic and neurohormonal interaction need urgent referral for coronary intervention poor outcome |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients aged 18 yrs or older presenting with AHF
Key inclusion criteria (1 listed)
- patients aged 18 yrs or older presenting with AHF
Key exclusion criteria (2 listed)
- Congenital heart disease
- acute and chronic liver diseases
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 |
|---|---|---|
| Avoiding the risk factorsExercise, Salt and lipid reduction in diet, smoking cessation | Behavioural | Acute coronary syndrome complicated by heart failure, Acute decompensated heart failure (de novo or as decompensation of chronic heart failure), Hypertensive acute heart failure, Pulmonary edema, cardiogenic shock |
Primary outcome
Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals
Time frame: baseline
assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF
1 secondary outcome
Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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. This study is not recruiting at the moment.
Hassan Ahmed contact
Hamdy Saad study chair
Sohag University
Haitham Mohammad study chair
Sohag University
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 Acute Heart Failure, run by Sohag 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 2 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Mohamed (+201117517685, Sara_mohamed_post@med.Sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals (time frame: baseline). 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 10 Jul 2024; AzTrials last refreshed its copy on 29 Oct 2026.