Heart Failure With Preserved Ejection FractionNCT05822622
Relationship Between Heart Failure With Preserved Ejection Fraction and Nonalcoholic Fatty Liver Disease.
An observational study of Heart Failure With Preserved Ejection Fraction and Non Alcoholic Fatty Liver, run by Sohag University at 2 sites in Egypt.
Trial summary
The aim of our study to determine the demography, relation between patients with heart failure with preserved ejection fraction and those with nonalcoholic fatty liver disease in Sohag university hospital. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Non Alcoholic Fatty Liver
- What is being tested?
- echocardiography
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 29 Apr 2023to 30 Aug 2023
- How long will I take part?
- 5 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients presented by heart failure with preserved ejection fraction and those with fatty liver disease
Inclusion Criteria: clinical diagnosis of heart failure with preserved ejection fraction.
clinical diagnosis of nonalcoholic fatty liver disease. -
Exclusion Criteria: rheumatic heart disease ,congenital heart disease , ischemic heart disease ,heart failure with reduced ejection fraction , hepatitis B virus , hepatitis C virus .
-
Trial locations and contacts
2 sites in 1 country.
Usama A Arafa, professor contact
Egypt2 sites
Asmaa elsayed khalifa
Sohag, El Monshah, 82515
Asmaa E khalifa, resident, 01021344185, asmaaelsayed@med.sohag.edu.eg
Usama A Arafa, professor, 01063064007
Asmaa E khalifa
Sohag, 82515
Asmaa E khalifa, Dr, 01021344185, asmaaelsayed@med.sohag.edu.eg
Usama A Arafa, prof, 01063064007
About this study
The aim of our study to determine the demography, relation between patients with heart failure with preserved ejection fraction and those with nonalcoholic fatty liver disease in Sohag university hospital.
Read the detailed description
type of the study cross sectional study to study the relationship between heart failure with preserved ejection fraction and nonalcoholic fatty liver disease.
- Being tested
- echocardiography
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyOther
Also called abdominal ultrasound and transient elastography
to determine finding of heart failure with preserved ejection fraction and non alcoholic fatty liver disease
| Study group | Role | What they receive |
|---|---|---|
| HFpEF(heart failure with preserved ejection fraction) | chronic heart failure with echocardiographic finding of LVEF (left ventricular ejection fraction) equal or more than 50% , diagnostic test :Abdominal ultrasound and transient elastography for detecting non alcoholic fatty liver disease . Receives: Other: echocardiography | |
| NAFLD(non alcoholic fatty liver disease) | ultrasound and transient elastographic finding of fatty liver disease, diagnostic test :echocardiography to determine heart failure with preserved ejection fraction . Receives: Other: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
collection of results of echocardiography (those detect HFpEF) with abdominal ultrasound and transient elastography results (those detect NAFLD) and find relationship between the results.
looking for relationship between echocardiographic findings (that detect heart failure with preserved ejection fraction) and finding in abdominal ultrasound and transient elastography (detection of nonalcoholic fatty liver disease) to detect the relationship between those two diseases.
Measured: up to 28 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start29 Apr 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Aug 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 Heart Failure With Preserved Ejection FractionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Elsayed Khalifa, Sohag University
- Investigators
- Aml K Ahmed, A professor, Study chair, Sohag UniversityAlshimaa L Hamed, lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822622
- Sponsor's protocol ID
- Soh-Med-23-02-03
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
PubMed 28785469
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Heart Failure With Preserved Ejection Fraction and Nonalcoholic Fatty Liver Disease.
- ClinicalTrials.gov ID
- NCT05822622
- Acronym / sponsor ID
- Soh-Med-23-02-03
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 29 Apr 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 21 Apr 2023 (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 of our study to determine the demography, relation between patients with heart failure with preserved ejection fraction and those with nonalcoholic fatty liver disease in Sohag university hospital.
Detailed description
type of the study cross sectional study to study the relationship between heart failure with preserved ejection fraction and nonalcoholic fatty liver disease.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF(heart failure with preserved ejection fraction) | – | Other: echocardiographychronic heart failure with echocardiographic finding of LVEF (left ventricular ejection fraction) equal or more than 50% , diagnostic test :Abdominal ultrasound and transient elastography for detecting non alcoholic fatty liver disease . |
| NAFLD(non alcoholic fatty liver disease) | – | Other: echocardiographyultrasound and transient elastographic finding of fatty liver disease, diagnostic test :echocardiography to determine heart failure with preserved ejection fraction . |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients presented by heart failure with preserved ejection fraction and those with fatty liver 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 |
|---|---|---|
| echocardiographyAlso: abdominal ultrasound and transient elastographyto determine finding of heart failure with preserved ejection fraction and non alcoholic fatty liver disease | Other | HFpEF(heart failure with preserved ejection fraction), NAFLD(non alcoholic fatty liver disease) |
Primary outcome
collection of results of echocardiography (those detect HFpEF) with abdominal ultrasound and transient elastography results (those detect NAFLD) and find relationship between the results.
Time frame: up to 28 weeks.
looking for relationship between echocardiographic findings (that detect heart failure with preserved ejection fraction) and finding in abdominal ultrasound and transient elastography (detection of nonalcoholic fatty liver disease) to detect the relationship between those two diseases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Results publication: PubMed 28785469Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
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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.
Usama A Arafa, professor contact
Aml K Ahmed, A professor study chair
Sohag University
Alshimaa L Hamed, lecturer study chair
Sohag University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Non Alcoholic Fatty Liver, run by Sohag University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Asmaa E khalifa, resident (01021344185, asmaaelsayed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collection of results of echocardiography (those detect HFpEF) with abdominal ultrasound and transient elastography results (those detect NAFLD) and find relationship between the results. (time frame: up to 28 weeks.). 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 NCT05822622, 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 21 Apr 2023.