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

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Brief Title

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

Official Title

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

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.
    

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


Primary Outcome

Heart failure


Condition

Pediatric Dilated Cardiomyopathy

Intervention

treatment of anemia.

Study Arms / Comparison Groups

 group with dilated cardiomyopathy without anemia
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

40

Start Date

February 2018

Completion Date

December 2018

Primary Completion Date

August 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

2 Months - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 0201096260950, [email protected]



Administrative Informations


NCT ID

NCT03214757

Organization ID

NA_0000XXX


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

, , 


Verification Date

January 2018