Congestive Heart FailureNCT04441346
Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients
An observational study of Congestive Heart Failure, run by Assiut University.
Trial summary
This study aims : To assess the frequency of heart failure in patients with end-stage renal disease on regular dialysis. To identify the risk factors of heart failure in patients with end-stage renal disease. To assess the impact of duration of dialysis on heart failure and its prognosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 289 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Nov 2021
- 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
- Adult, Older adult
Study population: Dialysis unit of Internal Medicine Department in Assiut University Hospital
Who may be able to join
- ESRD patient on regular hemodialysis
Who cannot join
- AKI patients on HD
- Patients discontinued therapy during the study period will be excluded.
- Patients with structural heart disease (congenital or valvular heart disease)
- Patients with obstructive or restrictive lung diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients Attending Assiut University Hosptial
This study aims :
To assess the frequency of heart failure in patients with end-stage renal disease on regular dialysis.
To identify the risk factors of heart failure in patients with end-stage renal disease.
To assess the impact of duration of dialysis on heart failure and its prognosis
Read the detailed description
Heart Failure is defined as a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill or eject blood with diagnosis relying on clinical examination and associated with significant mortality and morbidity. Congestive heart failure (CHF) is a cardiovascular complication in which the heart becomes unable to supply a sufficient amount of blood to meet the metabolic requirements and fulfill the body's oxygen demand.
CHF is an independent risk factor for early mortality in ESRD patients. More than half of all deaths among ESRD patients are due to cardiovascular disease (CVD). Cardiovascular changes secondary to renal dysfunction, including fluid overload, uremic cardiomyopathy, secondary hyperparathyroidism, anemia, altered lipid metabolism, and accumulation of gut microbiota-derived uremic toxins like trimethylamine N-oxidase (TMAO), contribute to the high risk for CVD in the ESRD population. Also, conventional hemodialysis (HD) itself poses myocardial stress and injury to the already compromised cardiovascular system in uremic patients.
The characteristics of cardiovascular dysfunction observed in dialysis patients are distinct from those noted in the general population. Although traditional cardiovascular risk factors in patients with end-stage renal disease (ESRD) are highly prevalent, they play only a partial role in the excessive cardiovascular morbidity and mortality of this population. The paradoxical association between several traditional risk factors, such as body mass index, blood pressure (BP) and serum cholesterol, and mortality have been previously reported.
In the ESRD population, Hemodialysis (HD) contributes itself to the development of CHF with sustained fluid overload a major cause of hypertension, heart failure, and mortality in patients with ESRD. We postulate that repeated myocardial micro-injury during maintenance hemodialysis may lead to irreversible cardiac dysfunction and subsequent heart failure and death in some patients.
- Conditions
- Congestive Heart Failure
- Being tested
- Echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyRadiation
test that uses high frequency sound waves (ultrasound) to make pictures of your heart.
| Study group | Role | What they receive |
|---|---|---|
| patients with recent hemodialysis(less than 6 month | Not described Receives: Radiation: Echocardiography | |
| patients on hemodialysis more than 6 months and l | Not described Receives: Radiation: Echocardiography | |
| patients on hemodialysis more than 5 years | Not described Receives: Radiation: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk factors of CHF in hemodialysis patients
identification of risk factors using demographic and disease characteristics of the patient as age, gender, systolic and diastolic blood pressure, dialysis access, frequency and duration of HD
Measured: July 2020 to July 2021
incidence of CHF in hemodialysis patients
identification of CHF in ESRD patients using echocardiography
Measured: July 2020 to July 2021
Secondary outcomes (1)
impact of duration of dialysis on heart failure
determine the extent of CHF in relation to duration of dialysis
Measured: July 2020 to July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Galal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441346
- Sponsor's protocol ID
- CHF in Dialysis patients
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients Attending Assiut University Hosptial
- ClinicalTrials.gov ID
- NCT04441346
- Acronym / sponsor ID
- CHF in Dialysis patients
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 22 Jun 2020 (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.
This study aims :
To assess the frequency of heart failure in patients with end-stage renal disease on regular dialysis.
To identify the risk factors of heart failure in patients with end-stage renal disease.
To assess the impact of duration of dialysis on heart failure and its prognosis
Detailed description
Heart Failure is defined as a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill or eject blood with diagnosis relying on clinical examination and associated with significant mortality and morbidity. Congestive heart failure (CHF) is a cardiovascular complication in which the heart becomes unable to supply a sufficient amount of blood to meet the metabolic requirements and fulfill the body's oxygen demand.
CHF is an independent risk factor for early mortality in ESRD patients. More than half of all deaths among ESRD patients are due to cardiovascular disease (CVD). Cardiovascular changes secondary to renal dysfunction, including fluid overload, uremic cardiomyopathy, secondary hyperparathyroidism, anemia, altered lipid metabolism, and accumulation of gut microbiota-derived uremic toxins like trimethylamine N-oxidase (TMAO), contribute to the high risk for CVD in the ESRD population. Also, conventional hemodialysis (HD) itself poses myocardial stress and injury to the already compromised cardiovascular system in uremic patients.
The characteristics of cardiovascular dysfunction observed in dialysis patients are distinct from those noted in the general population. Although traditional cardiovascular risk factors in patients with end-stage renal disease (ESRD) are highly prevalent, they play only a partial role in the excessive cardiovascular morbidity and mortality of this population. The paradoxical association between several traditional risk factors, such as body mass index, blood pressure (BP) and serum cholesterol, and mortality have been previously reported.
In the ESRD population, Hemodialysis (HD) contributes itself to the development of CHF with sustained fluid overload a major cause of hypertension, heart failure, and mortality in patients with ESRD. We postulate that repeated myocardial micro-injury during maintenance hemodialysis may lead to irreversible cardiac dysfunction and subsequent heart failure and death in some patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with recent hemodialysis(less than 6 month | – | Radiation: Echocardiography |
| patients on hemodialysis more than 6 months and l | – | Radiation: Echocardiography |
| patients on hemodialysis more than 5 years | – | Radiation: Echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Dialysis unit of Internal Medicine Department in Assiut University Hospital
Key inclusion criteria (1 listed)
- ESRD patient on regular hemodialysis
Key exclusion criteria (4 listed)
- AKI patients on HD
- Patients discontinued therapy during the study period will be excluded.
- Patients with structural heart disease (congenital or valvular heart disease)
- Patients with obstructive or restrictive lung diseases.
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 |
|---|---|---|
| Echocardiographytest that uses high frequency sound waves (ultrasound) to make pictures of your heart. | Radiation | patients on hemodialysis more than 5 years, patients on hemodialysis more than 6 months and l, patients with recent hemodialysis(less than 6 month |
Primary outcome
risk factors of CHF in hemodialysis patients
Time frame: July 2020 to July 2021
identification of risk factors using demographic and disease characteristics of the patient as age, gender, systolic and diastolic blood pressure, dialysis access, frequency and duration of HD
incidence of CHF in hemodialysis patients
Time frame: July 2020 to July 2021
identification of CHF in ESRD patients using echocardiography
1 secondary outcome
impact of duration of dialysis on heart failure
Time frame: July 2020 to July 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, 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 4 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 22 Jun 2020. 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 Esraa Galal (0201094424433, esraagalal.eg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk factors of CHF in hemodialysis patients (time frame: July 2020 to July 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2020.