Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients

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

Study Overview

• Status: Unknown
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Radiation: Echocardiography

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 Type: Observational
• Enrollment (Anticipated): 289

Contacts and Locations

• Study Contact: Name: Esraa Galal; Phone Number: 0201094424433; Email: esraagalal.eg@gmail.com
• Study Contact Backup: Name: Dina Ali, DR; Phone Number: 0201063040703; Email: dinaalihamad@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dialysis unit of Internal Medicine Department in Assiut University Hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with recent hemodialysis(less than 6 month	Radiation: Echocardiography; test that uses high frequency sound waves (ultrasound) to make pictures of your heart.
patients on hemodialysis more than 6 months and l	Radiation: Echocardiography; test that uses high frequency sound waves (ultrasound) to make pictures of your heart.
patients on hemodialysis more than 5 years	Radiation: Echocardiography; test that uses high frequency sound waves (ultrasound) to make pictures of your heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
incidence of CHF in hemodialysis patients	identification of CHF in ESRD patients using echocardiography	July 2020 to July 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of duration of dialysis on heart failure	determine the extent of CHF in relation to duration of dialysis	July 2020 to July 2021

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CHF in Dialysis patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No