Short Term Outcome of Acute Heart Failure in Diabetic and Non Diabetic Patients

NCT ID: NCT06447467

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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

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Acute Heart Failure Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic patients

Diabetic patients

pro BNP

Intervention Type DIAGNOSTIC_TEST

Test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms

Non Diabetic patients

Non Diabetic patients

pro BNP

Intervention Type DIAGNOSTIC_TEST

Test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms

Interventions

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pro BNP

Test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years old or older .
* Admitted to the Coronary Care Unit with acute HF.
* Patients with new onset heart failure.
* Decompensated chronic HF.

Exclusion Criteria

* Aged under 18 years old.
* Patients with chronic HF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mena Monir Thabet

Resident at Internal medicine departement Sohag Universirty Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdy M Amin, Professor

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mina M Thabet, Resident

Role: CONTACT

01018318271

Ali T Ali, Professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21060326 (View on PubMed)

Shaw 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.

Reference Type BACKGROUND
PMID: 19896746 (View on PubMed)

Ambrosy 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.

Reference Type BACKGROUND
PMID: 24491689 (View on PubMed)

Cook 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.

Reference Type BACKGROUND
PMID: 19797329 (View on PubMed)

Other Identifiers

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Soh-Med-24-05-13MS

Identifier Type: -

Identifier Source: org_study_id

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