Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients

Congestive Heart Failure Clinical Trial

Official title:

Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients Attending Assiut University Hosptial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04441346
• Other study ID #: CHF in Dialysis patients
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: November 2021

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: Esraa Galal
• Phone: 0201094424433
• Email: esraagalal.eg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 289
• Est. completion date: November 2021
• Est. primary completion date: October 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Radiation:
• Echocardiography
test that uses high frequency sound waves (ultrasound) to make pictures of your heart.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	July 2020 to July 2021
Primary	incidence of CHF in hemodialysis patients	identification of CHF in ESRD patients using echocardiography	July 2020 to July 2021
Secondary	impact of duration of dialysis on heart failure	determine the extent of CHF in relation to duration of dialysis	July 2020 to July 2021