Prediabetes and Newly Diagnosed Diabetes in Chronic Heart Failure

December 30, 2022 updated by: Heba Saber AbdelKader, Sohag University

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

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

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

Study Contact Backup

  • Name: Hassan A Hasanien, prof
  • Phone Number: 01003459741

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients presented by heart failure NYHA class 2 or more and admitted to Sohag University hospital according to inclusion and exclusion criterea

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure hospitalization.
Time Frame: 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.
From date of randomization up to 1 month

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

December 30, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Anticipated)

January 30, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Estimate)

January 2, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diabetes and heart failure

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.

Clinical Trials on Chronic Heart Failure

Clinical Trials on hbA1C

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe