Clinical trial NCT04441346: Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients
Official title: Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients Attending Assiut University Hosptial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dialysis unit of Internal Medicine Department in Assiut University Hospital

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* ESRD patient on regular hemodialysis

Exclusion Criteria:

* 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.

Primary outcomes:
measure: risk factors of CHF in hemodialysis patients
timeFrame: July 2020 to July 2021
measure: incidence of CHF in hemodialysis patients
timeFrame: July 2020 to July 2021
Secondary outcomes:
measure: impact of duration of dialysis on heart failure
timeFrame: July 2020 to July 2021
Other outcomes:
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