Prediabetes and Newly Diagnosed Diabetes in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Prevalence of Prediabetes and Newly Diagnosed Diabetes in Patients With HFpEF( Heart Failure With Preserved Ejection Fraction) and HFrEF(Heart Failure With Reduced Ejection Fraction) in Sohag University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05090202
• Other study ID #: diabetes and heart failure
• Status: Not yet recruiting
• Start date: December 30, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: December 2022
• Source: Sohag University
• Contact: Heba S AbdelKader
• Phone: 01067892227
• Email: heba011214[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim the study is to determine the prevalence of prediabetic dysglycemia and newly diagnosed diabetes among individuals with CHF(chronic heart failure) in sohag university hospital patients .

Description:

• Prospective study to:

1. study the differences in the prevalence of Prediabetes and newly diagnosed diabetes among the patients with HFrEF and HFpEF

2. The effect of dysglycemia on prognosis of patients with chronic heart failure.

3. The effect of early discover of diabetes mellitus on prognosis of patients with chronic heart failure

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• All patients presented by heart failure

• 18 years or older

• Classified according to NYHA " New York Heart Association" classification from NYHA class 2 and more

Exclusion Criteria:

• Overt diabetes

• Rheumatic Heart Disease

• Congenital heart disease

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Prediabetic State

Intervention

Diagnostic Test:
• hbA1C
hbA1C will be measured for all patients and results will be analysed into Non diabetic, Prediabetic and Diabetic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (1)

Nielsen R, Jorsal A, Iversen P, Tolbod L, Bouchelouche K, Sorensen J, Harms HJ, Flyvbjerg A, Botker HE, Wiggers H. Heart failure patients with prediabetes and newly diagnosed diabetes display abnormalities in myocardial metabolism. J Nucl Cardiol. 2018 Feb;25(1):169-176. doi: 10.1007/s12350-016-0622-0. Epub 2016 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure hospitalization.	Heart failure hospitalization or cardiovascular (CV) death, and all-cause death, and estimated hazard ratios (HR) by use of multivariable Cox regression models.	From date of randomization up to 1 month