Acute Heart FailureNCT06447467
Short Term Outcome of Acute Heart Failure in Diabetic and Non Diabetic Patients
An observational study of Acute Heart Failure and Diabetes Mellitus, run by Sohag University at 1 site in Egypt.
Trial summary
Around 26 million people suffer from heart failure (HF) globally, and the prevalence is increasing with an increasing longevity, prevalence of risk factors, and improved survival in patients with cardiovascular diseases In Egypt, HF is the primary cause of hospitalization among patients aged > 65 years . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure, Diabetes Mellitus
- What is being tested?
- pro BNP
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Aged 18 years old or older . * Admitted to the Coronary Care Unit with acute HF. * Patients with new onset heart failure. * Decompensated chronic HF.
Who may be able to join
- Aged 18 years old or older .
- Admitted to the Coronary Care Unit with acute HF.
- Patients with new onset heart failure.
- Decompensated chronic HF.
Who cannot join
- Aged under 18 years old.
- Patients with chronic HF
Trial locations and contacts
1 site in 1 country.
Ali T Ali, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, Professor
About this study
Around 26 million people suffer from heart failure (HF) globally, and the prevalence is increasing with an increasing longevity, prevalence of risk factors, and improved survival in patients with cardiovascular diseases In Egypt, HF is the primary cause of hospitalization among patients aged > 65 years . Hospitalization for HF is associated with a high mortality and rate of re-hospitalization . Around 75% patients with HF have ≥ 1 comorbidity, and these comorbidities make overall clinical outcomes worse . In a recent meta-analysis, patients with diabetes mellitus (DM) were suggested to have a two-fold increase in the risk of HF . DM is present in ~ 35% patients hospitalized with acute HF . Multiple factors such as ischemia, hypertension, and extracellular fluid volume expansion are involved in the pathogenesis of HF in DM.
Read the detailed description
The prevalence of both heart failure (HF) and diabetes has increased over the last decades and is expected to do so in the upcoming decades . Therefore, the presence of diabetes in patients with HF is also likely to increase and this is anticipated to become a major health concern. The actual prevalence of diabetes in patients with acute HF in different registries has varied but may be as high as 45% . Because the structure and function of the heart is directly influenced by the presence of diabetes, diabetes is to be considered to represent more than just a co morbid condition in HF .
Diabetes has been shown to be an independent risk factor for the development of HF . Moreover, this risk has been shown to be age and sex dependent. Compared with patients without diabetes, the presence of diabetes doubles the risk of HF in men, and the risk of developing HF in women may be as much as four times higher . These associations may even be stronger in younger patients. Furthermore, the presence of diabetes has been associated with a longer duration of hospitalization and higher rates of rehospitalization among patients with acute HF. Importantly, in patients with HF, it has been established that the presence of diabetes is not only associated with an increased cardiovascular morbidity but also with an increased mortality
- Conditions
- Acute Heart Failure, Diabetes Mellitus
- Being tested
- pro BNP
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pro BNPDiagnostic test
Test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Diabetic patients Receives: Diagnostic Test: pro BNP | |
| Non Diabetic patients | Non Diabetic patients Receives: Diagnostic Test: pro BNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro BNP level
A pro BNP test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Monir Thabet, Sohag University
- Investigators
- Magdy M Amin, Professor, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447467
- Sponsor's protocol ID
- Soh-Med-24-05-13MS
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011 Jan;8(1):30-41. doi: 10.1038/nrcardio.2010.165. Epub 2010 Nov 9.
PubMed 21060326Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
PubMed 19896746Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
PubMed 24491689Cook SA, Varela-Carver A, Mongillo M, Kleinert C, Khan MT, Leccisotti L, Strickland N, Matsui T, Das S, Rosenzweig A, Punjabi P, Camici PG. Abnormal myocardial insulin signalling in type 2 diabetes and left-ventricular dysfunction. Eur Heart J. 2010 Jan;31(1):100-11. doi: 10.1093/eurheartj/ehp396. Epub 2009 Oct 1.
PubMed 19797329
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome of Acute Heart Failure in Diabetic and Non Diabetic Patients
- ClinicalTrials.gov ID
- NCT06447467
- Acronym / sponsor ID
- Soh-Med-24-05-13MS
- Conditions
- Acute Heart Failure, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 7 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.
Around 26 million people suffer from heart failure (HF) globally, and the prevalence is increasing with an increasing longevity, prevalence of risk factors, and improved survival in patients with cardiovascular diseases In Egypt, HF is the primary cause of hospitalization among patients aged > 65 years . Hospitalization for HF is associated with a high mortality and rate of re-hospitalization . Around 75% patients with HF have ≥ 1 comorbidity, and these comorbidities make overall clinical outcomes worse . In a recent meta-analysis, patients with diabetes mellitus (DM) were suggested to have a two-fold increase in the risk of HF . DM is present in ~ 35% patients hospitalized with acute HF . Multiple factors such as ischemia, hypertension, and extracellular fluid volume expansion are involved in the pathogenesis of HF in DM.
Detailed description
The prevalence of both heart failure (HF) and diabetes has increased over the last decades and is expected to do so in the upcoming decades . Therefore, the presence of diabetes in patients with HF is also likely to increase and this is anticipated to become a major health concern. The actual prevalence of diabetes in patients with acute HF in different registries has varied but may be as high as 45% . Because the structure and function of the heart is directly influenced by the presence of diabetes, diabetes is to be considered to represent more than just a co morbid condition in HF .
Diabetes has been shown to be an independent risk factor for the development of HF . Moreover, this risk has been shown to be age and sex dependent. Compared with patients without diabetes, the presence of diabetes doubles the risk of HF in men, and the risk of developing HF in women may be as much as four times higher . These associations may even be stronger in younger patients. Furthermore, the presence of diabetes has been associated with a longer duration of hospitalization and higher rates of rehospitalization among patients with acute HF. Importantly, in patients with HF, it has been established that the presence of diabetes is not only associated with an increased cardiovascular morbidity but also with an increased mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Diagnostic Test: pro BNPDiabetic patients |
| Non Diabetic patients | – | Diagnostic Test: pro BNPNon Diabetic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Aged 18 years old or older . * Admitted to the Coronary Care Unit with acute HF. * Patients with new onset heart failure. * Decompensated chronic HF.
Key inclusion criteria (4 listed)
- Aged 18 years old or older .
- Admitted to the Coronary Care Unit with acute HF.
- Patients with new onset heart failure.
- Decompensated chronic HF.
Key exclusion criteria (2 listed)
- Aged under 18 years old.
- Patients with chronic HF
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 |
|---|---|---|
| pro BNPTest is mainly used to help diagnose or rule out heart failure in a person who is having symptoms | Diagnostic test | Diabetic patients, Non Diabetic patients |
Primary outcome
Pro BNP level
Time frame: 6 months
A pro BNP test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Background: PubMed 21060326Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011 Jan;8(1):30-41. doi: 10.1038/nrcardio.2010.165. Epub 2010 Nov 9.
- Background: PubMed 19896746Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
- Background: PubMed 24491689Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
- Background: PubMed 19797329Cook SA, Varela-Carver A, Mongillo M, Kleinert C, Khan MT, Leccisotti L, Strickland N, Matsui T, Das S, Rosenzweig A, Punjabi P, Camici PG. Abnormal myocardial insulin signalling in type 2 diabetes and left-ventricular dysfunction. Eur Heart J. 2010 Jan;31(1):100-11. doi: 10.1093/eurheartj/ehp396. Epub 2009 Oct 1.
- 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. This study is not recruiting at the moment.
Ali T Ali, Professor contact
Magdy M Amin, Professor principal investigator
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 and Diabetes Mellitus, 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 4 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 20 Jun 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 Mina M Thabet, Resident (01018318271, menamonir@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pro BNP level (time frame: 6 months). 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 NCT06447467, which also lists 4 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 20 Jun 2024.