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

NCT03214757 | Unknown

• 1 other identifier: NA_0000XXX
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pediatric Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Well-Being Scale

  three months duration after start of the study

Study Arms (2)

group with dilated cardiomyopathy without anemia

group with dilated cardiomyopathy with anemia

Other: treatment of anemia.

Interventions

treatment of anemia. OTHER

drug treatment of anemia.

group with dilated cardiomyopathy with anemia

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Nagwa Ali Mohammed, MD

CONTACT

0201096260950; Namma65@yahoo.com

Osama Mahmoud El-Asheer, MD

CONTACT

0201001348864; Asheer1970@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: February 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 10, 2018

Record last verified: 2018-01