A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy

Dilated cardiomyopathy is a heart muscle disorder characterized by systolic dysfunction and dilation of the left or both ventricles.Dilated cardiomyopathy can develop in people of any age or ethnicity, although it is more common in male than female persons occurring at a ratio of about three to one in male to female persons.

Dilated cardiomyopathy is the predominant cause of cardiomyopathy in pediatric populations. Annual incidence in pediatric populations has been reported to be much lower than one to one hundred seventy thousand in the United States and one to one hundred forty thousand in Australia.

Although pediatric dilated cardiomyopathy has a lower annual incidence than adult dilated cardiomyopathy, the outcome for pediatric dilated cardiomyopathy patients is particularly severe.

Dilated cardiomyopathy is the most frequent cause of heart transplantation in pediatric patients. Data from international pediatric dilated cardiomyopathy registries indicate that the rates of death or heart transplantation over one and five year periods were thirty one percent and forty six percent, respectively.

Onset of dilated cardiomyopathy is usually insidious but may be acute in as many at twenty five percent of patients. Approximately fifty percent of patients with dilated cardiomyopathy have a history of preceding viral illness.

Study Overview

• Status: Unknown
• Conditions: Pediatric Dilated Cardiomyopathy
• Intervention / Treatment: Other: treatment of anemia.

Detailed Description

The clinical diagnosis of dilated cardiomyopathy is made from history, physical examination, and noninvasive testing. The initial clinical manifestations of dilated heart failure are generally those of respiratory distress secondary to congestion of the pulmonary and systemic venous circulations.

Pallor, irritability, diaphoresis, tachypnea, easy fatigability are characteristics.

Failure to grow may also occur. In older patients, a history of orthopnea, nocturnal cough, and dyspnea provoked by minimal activity can be elicited and generally precede evidence of systemic venous congestion. In rapidly progressive disease, dominant symptoms are often abdominal distention, right upper quadrant pain, and nausea. Less often, initial symptoms in childhood include arrhythmias, syncope, neurologic problems (seizures or delayed development), vomiting, abdominal distention, or fever.

Although as many as fifty percent of children with cardiomyopathy and heart failure give a history of a nonspecific febrile illness within three months of presentation, no evidence of myocarditis can usually be found on biopsy.'Physical signs vary with the stage of the disease.

Signs of congestive heart failure are frequent, and include tachypnea,tachycardia, diaphoresis, hepatomegaly, pallor, and, in advanced cases, hypotension and shock.

Failure to thrive may be present if, heart failure has been long standing. Patients are generally not cyanotic. Wheezing may be heard; however, rales are infrequent, especially in infants.

Neck vein distension is common, the external jugular crest reflecting mean right atrial pressure, the internal jugular exhibiting a prominent V wave indicative of tricuspid regurgitation.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All infants and children with dilated cardiomyopathy who are diagnosed clinically and by echocardiography attending cardiology outpatient clinic at Assiut University Children Hospital.

Description

Inclusion Criteria:

• All infants and children with dilated cardiomyopathy who are diagnosed clinically and by echocardiography attending cardiology outpatient clinic at Assiut University Children Hospital will be included.

Exclusion Criteria:

• Infants age less than two months.
• Infants with hemolytic anemias.
• Patients with congestive heart failure due to congenital heart disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group with dilated cardiomyopathy without anemia
group with dilated cardiomyopathy with anemia	Other: treatment of anemia.; drug treatment of anemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure	Through clinical manifestations of heart of heart failure and echocardiographic assesment of ventricular function	four months duration after start of the study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Well-Being Scale	To measure health related quality of life, to monitor the health of populations over time, or to evaluate the efficacy and effectiveness of clinical therapies of practices using a preference weighted self administered measure.	three months duration after start of the study

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: NA_0000XXX

Drug and device information, study documents

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