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

June 17, 2024 updated by: Mena Monir Thabet, Sohag University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ali T Ali, professor

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic patients
Diagnostic test: pro BNP
Test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms
Non Diabetic patients
Diagnostic test: pro BNP
Test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Magdy M Amin, Professor, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-05-13MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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