Heart FailureNCT06453967
Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
An observational study of Heart Failure, run by Assiut University.
Trial summary
To evaluate the effect of blood glucose level at admission and glucose variability during ICU admission and their effect on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- blood glucose levels
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed as acute decompensated heart failure and admitted to critical care unit will be recurited in this study either diabetic or not
Who may be able to join
- All patients admitted with acute decompensated heart failure will be recruited in the study.
Who cannot join
- Patients on chronic steroid therapy Patients diagnosed with right sided heart failure due to chest disease Patients with malignancy
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the effect of blood glucose level at admission and glucose variability during ICU admission and their effect on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure
Read the detailed description
Stress hyperglycemia is a physiological response of blood glucose levels to stressful events or severe diseases through enhanced inflammatory or neuro-hormonal activation , typically reflecting the severity of the corresponding disease.
Diabetes mellitus may lead to hyperglycemia. However, it can happen as a result of stress hormones in crucial situations as well as in illness states, and is referred to as "Stress Hyperglycemia". Other names for this syndrome include "New onset Hyperglycemia", "In hospital Hyperglycemia", "Admission Hyperglycemia", "New Hyperglycemia", and "reactive Hyperglycemia". The prevalence of admission hyperglycaemia ranges from 25 to 50% depending on the hyperglycaemia definition cut-off adopted. The American Heart Association and the Endocrine Society Clinical Guidelines defined stress hyperglycaemia as a random plasma glucose level above 140 mg/dL at any given time for both diabetic and nondiabetic hospitalized patients.Studies have shown that an elevated admission blood glucose level, in correlation with a specific condition, such as: myocardial infarction, stroke, heart failure or pneumonia is associated with a higher in-hospital mortality, increased length of hospital stay, and a higher rate of in-hospital complications.
Heart failure (HF) is a complex clinical syndrome that results from structural or functional impairment of ventricular filling or ejection. Also, HF is a progressive condition with intermittent acute decompensation leading to poor prognosis despite established guideline-directed therapy.Acute decompensated heart failure is a common reason for frequent hospital admission and has been associated with increased short-term mortality and poor long-term prognosis. Admission hyperglycaemia can be useful in identifying high-risk group of acute heart failure or in the risk stratification of acute heart failure In addition to age, obesity and diabetes have been identified as important risk factors for heart failure, Heart failure often manifests as the first cardiovascular event in people with type 2 diabetes.Several potential mechanisms contributing to the development of heart failure in diabetes include renin-angiotensin-aldosterone system (RAAS) activation, mitochondrial dysfunction, oxidative stress, inflammation, changes in intracellular calcium homeostasis, increased formation of advanced glycation end products, and myocardial energy substrate alterations including increased free fatty acid utilization, decreased glucose utilization, and increased oxygen consumption, resulting in decreased cardiac efficiency .
Dysregulation of hyperglycemia and glycemic variability are associated with an increased risk of mortality in critically ill patients .
It is also to be noted that individuals with HF and pre-diabetes have a higher risk of all-cause mortality and cardiac outcomes compared to those with normoglycemia.
- Conditions
- Heart Failure
- Being tested
- blood glucose levels
- Keywords
- glucose variability
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood glucose levelsDiagnostic test
measurement of blood glucose level at admission ,during ICU admission and at discharge for patients with acute decompensated heart failure
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of glucose variability during ICU admission on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure ▪
Glycaemic variability can be measured by Standard deviation of glucose, Coefficient of variation of glucose, Mean amplitude of glucose excursion ,glycemic lability index
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 posted12 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salma hamdy mahmoud haridi, Assiut University
- Investigators
- Ahmed Obeid Allah, Phd, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453967
- Sponsor's protocol ID
- 2024-04-22-001
- Status last verified
- Jun 2024
- First submitted
- 15 Apr 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou Y, Liu L, Huang H, Li N, He J, Yao H, Tang X, Chen X, Zhang S, Shi Q, Qu F, Wang S, Wang M, Shu C, Zeng Y, Tian H, Zhu Y, Su B, Li S; WECODe Study Group. 'Stress hyperglycemia ratio and in-hospital prognosis in non-surgical patients with heart failure and type 2 diabetes. Cardiovasc Diabetol. 2022 Dec 26;21(1):290. doi: 10.1186/s12933-022-01728-w.
PubMed 36572923Djupsjo C, Kuhl J, Andersson T, Lundback M, Holzmann MJ, Nystrom T. Admission glucose as a prognostic marker for all-cause mortality and cardiovascular disease. Cardiovasc Diabetol. 2022 Nov 26;21(1):258. doi: 10.1186/s12933-022-01699-y.
PubMed 36435766Paolisso P, Foa A, Bergamaschi L, Angeli F, Fabrizio M, Donati F, Toniolo S, Chiti C, Rinaldi A, Stefanizzi A, Armillotta M, Sansonetti A, Magnani I, Iannopollo G, Rucci P, Casella G, Galie N, Pizzi C. Impact of admission hyperglycemia on short and long-term prognosis in acute myocardial infarction: MINOCA versus MIOCA. Cardiovasc Diabetol. 2021 Sep 24;20(1):192. doi: 10.1186/s12933-021-01384-6.
PubMed 34560876Lee HY, Oh BH. Paradigm Shifts of Heart Failure Therapy: Do We Need Another Paradigm? Int J Heart Fail. 2020 Apr 6;2(3):145-156. doi: 10.36628/ijhf.2020.0010. eCollection 2020 Jul.
PubMed 36262366Kattel S, Kasai T, Matsumoto H, Yatsu S, Murata A, Kato T, Suda S, Hiki M, Takagi A, Daida H. Association between elevated blood glucose level on admission and long-term mortality in patients with acute decompensated heart failure. J Cardiol. 2017 Apr;69(4):619-624. doi: 10.1016/j.jjcc.2016.05.013. Epub 2016 Aug 21.
PubMed 27554050Cho JY, Kim KH, Lee SE, Cho HJ, Lee HY, Choi JO, Jeon ES, Kim MS, Kim JJ, Hwang KK, Chae SC, Baek SH, Kang SM, Choi DJ, Yoo BS, Ahn Y, Park HY, Cho MC, Oh BH. Admission Hyperglycemia as a Predictor of Mortality in Acute Heart Failure: Comparison between the Diabetics and Non-Diabetics. J Clin Med. 2020 Jan 6;9(1):149. doi: 10.3390/jcm9010149.
PubMed 31935874Ceriello A, Catrinoiu D, Chandramouli C, Cosentino F, Dombrowsky AC, Itzhak B, Lalic NM, Prattichizzo F, Schnell O, Seferovic PM, Valensi P, Standl E; D&CVD EASD Study Group. Heart failure in type 2 diabetes: current perspectives on screening, diagnosis and management. Cardiovasc Diabetol. 2021 Nov 6;20(1):218. doi: 10.1186/s12933-021-01408-1.
PubMed 34740359Pop-Busui R, Januzzi JL, Bruemmer D, Butalia S, Green JB, Horton WB, Knight C, Levi M, Rasouli N, Richardson CR. Heart Failure: An Underappreciated Complication of Diabetes. A Consensus Report of the American Diabetes Association. Diabetes Care. 2022 Jul 7;45(7):1670-1690. doi: 10.2337/dci22-0014.
PubMed 35796765
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06453967
- Acronym / sponsor ID
- 2024-04-22-001
- Conditions
- Heart Failure
- Keywords
- glucose variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Jun 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.
To evaluate the effect of blood glucose level at admission and glucose variability during ICU admission and their effect on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure
Detailed description
Stress hyperglycemia is a physiological response of blood glucose levels to stressful events or severe diseases through enhanced inflammatory or neuro-hormonal activation , typically reflecting the severity of the corresponding disease.
Diabetes mellitus may lead to hyperglycemia. However, it can happen as a result of stress hormones in crucial situations as well as in illness states, and is referred to as "Stress Hyperglycemia". Other names for this syndrome include "New onset Hyperglycemia", "In hospital Hyperglycemia", "Admission Hyperglycemia", "New Hyperglycemia", and "reactive Hyperglycemia". The prevalence of admission hyperglycaemia ranges from 25 to 50% depending on the hyperglycaemia definition cut-off adopted. The American Heart Association and the Endocrine Society Clinical Guidelines defined stress hyperglycaemia as a random plasma glucose level above 140 mg/dL at any given time for both diabetic and nondiabetic hospitalized patients.Studies have shown that an elevated admission blood glucose level, in correlation with a specific condition, such as: myocardial infarction, stroke, heart failure or pneumonia is associated with a higher in-hospital mortality, increased length of hospital stay, and a higher rate of in-hospital complications.
Heart failure (HF) is a complex clinical syndrome that results from structural or functional impairment of ventricular filling or ejection. Also, HF is a progressive condition with intermittent acute decompensation leading to poor prognosis despite established guideline-directed therapy.Acute decompensated heart failure is a common reason for frequent hospital admission and has been associated with increased short-term mortality and poor long-term prognosis. Admission hyperglycaemia can be useful in identifying high-risk group of acute heart failure or in the risk stratification of acute heart failure In addition to age, obesity and diabetes have been identified as important risk factors for heart failure, Heart failure often manifests as the first cardiovascular event in people with type 2 diabetes.Several potential mechanisms contributing to the development of heart failure in diabetes include renin-angiotensin-aldosterone system (RAAS) activation, mitochondrial dysfunction, oxidative stress, inflammation, changes in intracellular calcium homeostasis, increased formation of advanced glycation end products, and myocardial energy substrate alterations including increased free fatty acid utilization, decreased glucose utilization, and increased oxygen consumption, resulting in decreased cardiac efficiency .
Dysregulation of hyperglycemia and glycemic variability are associated with an increased risk of mortality in critically ill patients .
It is also to be noted that individuals with HF and pre-diabetes have a higher risk of all-cause mortality and cardiac outcomes compared to those with normoglycemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed as acute decompensated heart failure and admitted to critical care unit will be recurited in this study either diabetic or not
Key inclusion criteria (1 listed)
- All patients admitted with acute decompensated heart failure will be recruited in the study.
Key exclusion criteria (1 listed)
- Patients on chronic steroid therapy Patients diagnosed with right sided heart failure due to chest disease Patients with malignancy
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 |
|---|---|---|
| blood glucose levelsmeasurement of blood glucose level at admission ,during ICU admission and at discharge for patients with acute decompensated heart failure | Diagnostic test | – |
Primary outcome
To evaluate the effect of glucose variability during ICU admission on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure ▪
Time frame: 1 year
Glycaemic variability can be measured by Standard deviation of glucose, Coefficient of variation of glucose, Mean amplitude of glucose excursion ,glycemic lability index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Background: PubMed 36572923Zhou Y, Liu L, Huang H, Li N, He J, Yao H, Tang X, Chen X, Zhang S, Shi Q, Qu F, Wang S, Wang M, Shu C, Zeng Y, Tian H, Zhu Y, Su B, Li S; WECODe Study Group. 'Stress hyperglycemia ratio and in-hospital prognosis in non-surgical patients with heart failure and type 2 diabetes. Cardiovasc Diabetol. 2022 Dec 26;21(1):290. doi: 10.1186/s12933-022-01728-w.
- Background: PubMed 36435766Djupsjo C, Kuhl J, Andersson T, Lundback M, Holzmann MJ, Nystrom T. Admission glucose as a prognostic marker for all-cause mortality and cardiovascular disease. Cardiovasc Diabetol. 2022 Nov 26;21(1):258. doi: 10.1186/s12933-022-01699-y.
- Background: PubMed 34560876Paolisso P, Foa A, Bergamaschi L, Angeli F, Fabrizio M, Donati F, Toniolo S, Chiti C, Rinaldi A, Stefanizzi A, Armillotta M, Sansonetti A, Magnani I, Iannopollo G, Rucci P, Casella G, Galie N, Pizzi C. Impact of admission hyperglycemia on short and long-term prognosis in acute myocardial infarction: MINOCA versus MIOCA. Cardiovasc Diabetol. 2021 Sep 24;20(1):192. doi: 10.1186/s12933-021-01384-6.
- Background: PubMed 36262366Lee HY, Oh BH. Paradigm Shifts of Heart Failure Therapy: Do We Need Another Paradigm? Int J Heart Fail. 2020 Apr 6;2(3):145-156. doi: 10.36628/ijhf.2020.0010. eCollection 2020 Jul.
- Background: PubMed 27554050Kattel S, Kasai T, Matsumoto H, Yatsu S, Murata A, Kato T, Suda S, Hiki M, Takagi A, Daida H. Association between elevated blood glucose level on admission and long-term mortality in patients with acute decompensated heart failure. J Cardiol. 2017 Apr;69(4):619-624. doi: 10.1016/j.jjcc.2016.05.013. Epub 2016 Aug 21.
- Background: PubMed 31935874Cho JY, Kim KH, Lee SE, Cho HJ, Lee HY, Choi JO, Jeon ES, Kim MS, Kim JJ, Hwang KK, Chae SC, Baek SH, Kang SM, Choi DJ, Yoo BS, Ahn Y, Park HY, Cho MC, Oh BH. Admission Hyperglycemia as a Predictor of Mortality in Acute Heart Failure: Comparison between the Diabetics and Non-Diabetics. J Clin Med. 2020 Jan 6;9(1):149. doi: 10.3390/jcm9010149.
- Background: PubMed 34740359Ceriello A, Catrinoiu D, Chandramouli C, Cosentino F, Dombrowsky AC, Itzhak B, Lalic NM, Prattichizzo F, Schnell O, Seferovic PM, Valensi P, Standl E; D&CVD EASD Study Group. Heart failure in type 2 diabetes: current perspectives on screening, diagnosis and management. Cardiovasc Diabetol. 2021 Nov 6;20(1):218. doi: 10.1186/s12933-021-01408-1.
- Background: PubMed 35796765Pop-Busui R, Januzzi JL, Bruemmer D, Butalia S, Green JB, Horton WB, Knight C, Levi M, Rasouli N, Richardson CR. Heart Failure: An Underappreciated Complication of Diabetes. A Consensus Report of the American Diabetes Association. Diabetes Care. 2022 Jul 7;45(7):1670-1690. doi: 10.2337/dci22-0014.
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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.
Ahmed Obeid Allah, Phd study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Assiut University.
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 1 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 salma Hamdy, master degree (01012681274, salmahamdy003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of glucose variability during ICU admission on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure ▪ (time frame: 1 year). 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 NCT06453967, which also lists 8 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 12 Jun 2024.