NCT05090202

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

Same day

First QC Date

September 13, 2021

Last Update Submit

December 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

HFmrEF "Heart failure with mildly reduced ejection fraction"

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

Diagnostic Test: hbA1C

HFpEF " Heart failure with preserved ejection fraction"

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

Diagnostic Test: hbA1C

Interventions

hbA1CDIAGNOSTIC_TEST

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"HFpEF " Heart failure with preserved ejection fraction"HFrEF " Heart failure with reduced ejection fraction"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • All patients presented by heart failure
  • years or older
  • Classified according to NYHA " New York Heart Association" classification from NYHA class 2 and more

You may not qualify if:

  • Overt diabetes
  • Rheumatic Heart Disease
  • Congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 27473218BACKGROUND

Central Study Contacts

Hassan A Hasanien, prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 22, 2021

Study Start

December 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

January 3, 2023

Record last verified: 2022-12