Chronic Heart FailureNCT05090202
Prediabetes and Newly Diagnosed Diabetes in Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Sohag University.
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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- hbA1C
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2022to 30 Jan 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Overt diabetes
- Rheumatic Heart Disease
- Congenital heart disease
Trial locations and contacts
No sites are listed yet.
Hassan A Hasanien, prof contact
About this study
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
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 .
Read the detailed description
- Prospective study to:
- study the differences in the prevalence of Prediabetes and newly diagnosed diabetes among the patients with HFrEF and HFpEF
- The effect of dysglycemia on prognosis of patients with chronic heart failure.
- The effect of early discover of diabetes mellitus on prognosis of patients with chronic heart failure
- Conditions
- Chronic Heart Failure
- Being tested
- hbA1C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hbA1CDiagnostic test
hbA1C will be measured for all patients and results will be analysed into Non diabetic, Prediabetic and Diabetic
| Study group | Role | What they receive |
|---|---|---|
| HFrEF " Heart failure with reduced ejection fraction" | chronic heart failure with echocardiographic finding of LVEF "Left ventricular ejection fraction" equal or less than 40% Receives: Diagnostic Test: hbA1C | |
| HFmrEF "Heart failure with mildly reduced ejection fraction" | chronic heart failure with echocardiographic finding of LVEF between 41% and 49% Receives: Diagnostic Test: hbA1C | |
| HFpEF " Heart failure with preserved ejection fraction" | chronic heart failure with echocardiographic finding of LVEF equal or more than 50% Receives: Diagnostic Test: hbA1C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start30 Dec 2022 (estimated)
- Primary completion30 Dec 2022
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Saber AbdelKader, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090202
- Sponsor's protocol ID
- diabetes and heart failure
- Status last verified
- Dec 2022
- First submitted
- 13 Sep 2021
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27473218
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05090202
- Acronym / sponsor ID
- diabetes and heart failure
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
- Prospective study to:
- study the differences in the prevalence of Prediabetes and newly diagnosed diabetes among the patients with HFrEF and HFpEF
- The effect of dysglycemia on prognosis of patients with chronic heart failure.
- The effect of early discover of diabetes mellitus on prognosis of patients with chronic heart failure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFrEF " Heart failure with reduced ejection fraction" | – | Diagnostic Test: hbA1Cchronic heart failure with echocardiographic finding of LVEF "Left ventricular ejection fraction" equal or less than 40% |
| HFmrEF "Heart failure with mildly reduced ejection fraction" | – | Diagnostic Test: hbA1Cchronic heart failure with echocardiographic finding of LVEF between 41% and 49% |
| HFpEF " Heart failure with preserved ejection fraction" | – | Diagnostic Test: hbA1Cchronic heart failure with echocardiographic finding of LVEF equal or more than 50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Overt diabetes
- Rheumatic Heart Disease
- Congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hbA1ChbA1C will be measured for all patients and results will be analysed into Non diabetic, Prediabetic and Diabetic | Diagnostic test | HFmrEF "Heart failure with mildly reduced ejection fraction", HFpEF " Heart failure with preserved ejection fraction", HFrEF " Heart failure with reduced ejection fraction" |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Background: PubMed 27473218Nielsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan A Hasanien, prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba S AbdelKader (01067892227, heba011214@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure hospitalization. (time frame: From date of randomization up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.