Pediatric Dilated CardiomyopathyNCT03214757
A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy
An observational study of Pediatric Dilated Cardiomyopathy, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Dilated Cardiomyopathy
- What is being tested?
- treatment of anemia.
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Infants age less than two months.
- Infants with hemolytic anemias.
- Patients with congestive heart failure due to congenital heart disease.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pediatric Dilated Cardiomyopathy
- Being tested
- treatment of anemia.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of anemia.Other
drug treatment of anemia.
| Study group | Role | What they receive |
|---|---|---|
| group with dilated cardiomyopathy without anemia | Not described | |
| group with dilated cardiomyopathy with anemia | Not described Receives: Other: treatment of anemia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure
Through clinical manifestations of heart of heart failure and echocardiographic assesment of ventricular function
Measured: four months duration after start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study startFeb 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Amar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214757
- Sponsor's protocol ID
- NA_0000XXX
- Status last verified
- Jan 2018
- First submitted
- 7 Jul 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03214757
- Acronym / sponsor ID
- NA_0000XXX
- Conditions
- Pediatric Dilated Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with dilated cardiomyopathy without anemia | – | – |
| group with dilated cardiomyopathy with anemia | – | Other: treatment of anemia. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Infants age less than two months.
- Infants with hemolytic anemias.
- Patients with congestive heart failure due to congenital heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment of anemia.drug treatment of anemia. | Other | group with dilated cardiomyopathy with anemia |
Primary outcome
Heart failure
Time frame: four months duration after start of the study
Through clinical manifestations of heart of heart failure and echocardiographic assesment of ventricular function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Dilated Cardiomyopathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagwa Ali Mohammed, MD (0201096260950, Namma65@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure (time frame: four months duration after start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.