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Prediabetes and Newly Diagnosed Diabetes in Chronic Heart Failure

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05090202
Collaborator
(none)
100
Enrollment
3.6
Anticipated Duration (Months)

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: hbA1C

Detailed 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

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Nov 18, 2021
Anticipated Primary Completion Date :
Mar 8, 2022
Anticipated Study Completion Date :
Mar 8, 2022

Arms and Interventions

Arm Intervention/Treatment
HFrEF " Heart failure with reduced ejection fraction"

chronic heart failure with echocardiographic finding of LVEF "Left ventricular ejection fraction" equal or less than 40%

Diagnostic Test: hbA1C
hbA1C will be measured for all patients and results will be analysed into Non diabetic, Prediabetic and Diabetic
HFmrEF "Heart failure with mildly reduced ejection fraction"

chronic heart failure with echocardiographic finding of LVEF between 41% and 49%

Diagnostic Test: hbA1C
hbA1C will be measured for all patients and results will be analysed into Non diabetic, Prediabetic and Diabetic
HFpEF " Heart failure with preserved ejection fraction"

chronic heart failure with echocardiographic finding of LVEF equal or more than 50%

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

Outcome Measures

Primary Outcome Measures

  1. Heart failure hospitalization. [From date of randomization up to 1 month]

    Heart failure hospitalization or cardiovascular (CV) death, and all-cause death, and estimated hazard ratios (HR) by use of multivariable Cox regression models.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Heba Saber AbdelKader, Principal Investigator, Sohag University
ClinicalTrials.gov Identifier:
NCT05090202
Other Study ID Numbers:
  • diabetes and heart failure
First Posted:
Oct 22, 2021
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Prediabetic State

Study Results

No Results Posted as of Nov 9, 2021