Heart Failure With Reduced Ejection FractionNCT03877887
Finding Gab in the Treatment of Heart Failure in Assiut University Hospital
An observational study of Heart Failure With Reduced Ejection Fraction, run by Assiut University.
Trial summary
Analyze the epidemiology and outcome of all patients with heart failure with reduced ejection fraction (HFrEF) presented to Asyut university hospital (AUH) and to identify factors associated with mortality and all-cause hospitalization at a duration of 6 months follow-up. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- echo cardiogram
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to May 2020
- 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 80 years
- All sexes
- Adult, Older adult
Study population: All patients presented to Assiut university hospital outpatient clinic, inpatient ward and CCU admission with heart failure reduced ejection fraction according to inclusion criteria for 6 months from March 2019 to August 2019.
Who may be able to join
- All patients > 18 years of age with left ventricular ejection fraction (LVEF) < 40 % with symptoms and signs of heart failure (according to ESC guidelines of acute and chronic heart failure 2016).
Who cannot join
- patients more than 80 years old
Trial locations and contacts
No sites are listed yet.
mohamed abdel ghany contact
About this study
Official title: Comparison of Treatment and Doses of Drugs in Patient With Heart Failure Reduced Ejection Fraction (HFREF) Between Asyut University Hospital and Guidelines of European Society 0f Cardiology (ESC)
Analyze the epidemiology and outcome of all patients with heart failure with reduced ejection fraction (HFrEF) presented to Asyut university hospital (AUH) and to identify factors associated with mortality and all-cause hospitalization at a duration of 6 months follow-up.
Read the detailed description
Heart failure (HF) is nowadays an important health problem and associated with high use of resources and healthcare cost, but the prevalence of heart failure is increasing due to better care and treatment of HF and to the aging of the population. Epidemiology of HF is changing and shifting towards a higher prevalence of patients with HF with preserved ejection fraction. Moreover, the outcome of HF is grim. The mortality rate is high and hospitalizations are frequent and associated with worse outcomes. The majority of studies that analyzed HF outcomes have focused on HF hospitalizations. However, in patients with HF, all-cause hospitalizations can affect up to 23-58% of the patients at 1-year follow-up and non-cardiovascular hospitalizations are associated with risk of subsequent mortality similar to cardiovascular hospitalizations. Despite the evidence that all-cause hospitalizations are detrimental in HF patients, few studies have analyzed whether the factors associated with all-cause and HF-hospitalizations are different in HF patients.
However, the characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome, However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome, However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve the management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome
- Being tested
- echo cardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echo cardiogramDiagnostic test
Assessment of left ventricular systolic and diastolic function
What is being measured
The primary outcome is the main question the study is designed to answer.
To find the percentage of patients treated at guidelines recommended doses
All patients presented to Assiut university hospital outpatient clinic, inpatient ward and CCU admission with heart failure reduced ejection fraction will be grouped according to Age ( Etiology,risk factors,severity of symptoms (according to NYHA score),hospitalizations , co-morbidity and treatment and doses they received and compare it to guidelines and follow for re-hospitalization and mortality.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (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 Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Assiut 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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Shnouda Halim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877887
- Sponsor's protocol ID
- heart failure in Assuit
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farre N, Vela E, Cleries M, Bustins M, Cainzos-Achirica M, Enjuanes C, Moliner P, Ruiz S, Verdu-Rotellar JM, Comin-Colet J. Real world heart failure epidemiology and outcome: A population-based analysis of 88,195 patients. PLoS One. 2017 Feb 24;12(2):e0172745. doi: 10.1371/journal.pone.0172745. eCollection 2017.
PubMed 28235067
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment and Doses of Drugs in Patient With Heart Failure Reduced Ejection Fraction (HFREF) Between Asyut University Hospital and Guidelines of European Society 0f Cardiology (ESC)
- ClinicalTrials.gov ID
- NCT03877887
- Acronym / sponsor ID
- heart failure in Assuit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 18 Mar 2019 (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.
Analyze the epidemiology and outcome of all patients with heart failure with reduced ejection fraction (HFrEF) presented to Asyut university hospital (AUH) and to identify factors associated with mortality and all-cause hospitalization at a duration of 6 months follow-up.
Detailed description
Heart failure (HF) is nowadays an important health problem and associated with high use of resources and healthcare cost, but the prevalence of heart failure is increasing due to better care and treatment of HF and to the aging of the population. Epidemiology of HF is changing and shifting towards a higher prevalence of patients with HF with preserved ejection fraction. Moreover, the outcome of HF is grim. The mortality rate is high and hospitalizations are frequent and associated with worse outcomes. The majority of studies that analyzed HF outcomes have focused on HF hospitalizations. However, in patients with HF, all-cause hospitalizations can affect up to 23-58% of the patients at 1-year follow-up and non-cardiovascular hospitalizations are associated with risk of subsequent mortality similar to cardiovascular hospitalizations. Despite the evidence that all-cause hospitalizations are detrimental in HF patients, few studies have analyzed whether the factors associated with all-cause and HF-hospitalizations are different in HF patients.
However, the characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome, However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome, However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome However, characteristics and outcome of HF patients are not well described in developing countries like Egypt. Documenting patients' characteristics and the outcome might improve the management of comorbidities associated with heart failure patients in Egypt as well as the disease outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients presented to Assiut university hospital outpatient clinic, inpatient ward and CCU admission with heart failure reduced ejection fraction according to inclusion criteria for 6 months from March 2019 to August 2019.
Key inclusion criteria (1 listed)
- All patients > 18 years of age with left ventricular ejection fraction (LVEF) < 40 % with symptoms and signs of heart failure (according to ESC guidelines of acute and chronic heart failure 2016).
Key exclusion criteria (1 listed)
- patients more than 80 years old
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 |
|---|---|---|
| echo cardiogramAssessment of left ventricular systolic and diastolic function | Diagnostic test | – |
Primary outcome
To find the percentage of patients treated at guidelines recommended doses
Time frame: six months
All patients presented to Assiut university hospital outpatient clinic, inpatient ward and CCU admission with heart failure reduced ejection fraction will be grouped according to Age ( Etiology,risk factors,severity of symptoms (according to NYHA score),hospitalizations , co-morbidity and treatment and doses they received and compare it to guidelines and follow for re-hospitalization and mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Background: PubMed 28235067Farre N, Vela E, Cleries M, Bustins M, Cainzos-Achirica M, Enjuanes C, Moliner P, Ruiz S, Verdu-Rotellar JM, Comin-Colet J. Real world heart failure epidemiology and outcome: A population-based analysis of 88,195 patients. PLoS One. 2017 Feb 24;12(2):e0172745. doi: 10.1371/journal.pone.0172745. eCollection 2017.
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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.
mohamed abdel ghany contact
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by Assiut 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 1 inclusion and 1 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 19 Mar 2019. 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 abanoub shnouda (201270024800, abanoubshnouda92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find the percentage of patients treated at guidelines recommended doses (time frame: six months). 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 NCT03877887, 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 19 Mar 2019.