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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05090202
Other study ID # diabetes and heart failure
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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