CardiomyopathiesNCT07858474
Nutritional Assessment in Children With Cardiomyopathy
An observational study of Cardiomyopathies and Malnutrition, run by Assiut University.
Trial summary
This cross-sectional study aims to determine the prevalence and pattern of malnutrition (acute wasting, chronic stunting, and micronutrient deficiency) among children with cardiomyopathy attending the Pediatric Cardiology Unit at Assiut University Children's Hospital. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cardiomyopathies, Malnutrition
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 25 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 1 month to 18 years with an established diagnosis of cardiomyopathy (dilated, hypertrophic, or restrictive) confirmed by echocardiography, attending or admitted to the Pediatric Cardiology Unit at Assiut University Children's Hospital.
Who may be able to join
- Children aged 1 month to 18 years.
- Established diagnosis of cardiomyopathy (dilated, hypertrophic, or restrictive) confirmed by echocardiography.
- Attending or admitted to the Pediatric Cardiology Unit at Assiut University Children's Hospital.
- Written informed consent from parent/legal guardian.
Who cannot join
- Known chronic conditions with an independent, primary effect on nutritional status (e.g., celiac disease, chronic kidney disease, malignancy).
- Genetic/metabolic syndromes with intrinsic growth failure unrelated to cardiac status.
- Refusal of parental/guardian informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nutritional Assessment in Children With Cardiomyopathy: Prevalence and Pattern of Malnutrition
This cross-sectional study aims to determine the prevalence and pattern of malnutrition (acute wasting, chronic stunting, and micronutrient deficiency) among children with cardiomyopathy attending the Pediatric Cardiology Unit at Assiut University Children's Hospital.
Read the detailed description
Cardiomyopathy in children encompasses a heterogeneous group of primary myocardial disorders (dilated, hypertrophic, and restrictive) that represent a leading cause of chronic heart failure and a common indication for heart transplantation in the pediatric age group.
Malnutrition is now recognized as a common and clinically significant comorbidity in pediatric cardiomyopathy. Data from the Pediatric Cardiomyopathy Registry indicate that nearly a quarter of children with dilated cardiomyopathy are malnourished at presentation, while pooled estimates from adult heart failure populations report a malnutrition prevalence approaching half of all patients, with malnutrition independently associated with increased mortality.
This cross-sectional study will include children aged 1 month to 18 years with an established diagnosis of cardiomyopathy confirmed by echocardiography. Nutritional status will be assessed using anthropometric measurements (weight, height, MUAC, BMI-for-age z-scores), the STRONGkids screening tool, biochemical markers, and dietary assessment. The prevalence and pattern of malnutrition will be determined.
- Conditions
- Cardiomyopathies, Malnutrition
- Keywords
- Cardiomyopathy, STRONGkids, Malnutrition, Nutritional assessment, Pediatric, Assiut
- Medical subject headings
- Cardiomyopathies, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children With Cardiomyopathy | Children aged 1 month to 18 years with an established diagnosis of cardiomyopathy (dilated, hypertrophic, or restrictive) confirmed by echocardiography, attending or admitted to the Pediatric Cardiology Unit at Assiut University Children's Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title: Prevalence of malnutrition
Proportion of children with cardiomyopathy who have malnutrition based on anthropometric z-scores according to WHO growth standards.
Measured: Baseline
Secondary outcomes (5)
Proportion of children at nutritional risk by STRONGkids
Proportion of children classified as at nutritional risk according to the STRONGkids screening tool.
Measured: Baseline
Mean left ventricular ejection fraction
Mean left ventricular ejection fraction (LVEF) measured by echocardiography in percentage.
Measured: Baseline
Mean serum albumin
Mean serum albumin level in g/dL.
Measured: Baseline
Mean body mass index for age z-score
Mean BMI-for-age z-score according to WHO growth standards.
Measured: Baseline
Proportion of children with feeding difficulties
Proportion of children with reported feeding difficulties assessed by structured dietary assessment.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Abd El-Aziz Anwar Abd EL-Aziz, Assiut University
- Investigators
- Gamal A Asker, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858474
- Sponsor's protocol ID
- Nutrition-CMP-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment in Children With Cardiomyopathy: Prevalence and Pattern of Malnutrition
- ClinicalTrials.gov ID
- NCT07858474
- Acronym / sponsor ID
- Nutrition-CMP-Assiut-2026
- Conditions
- Cardiomyopathies, Malnutrition
- Keywords
- Cardiomyopathy, STRONGkids, Malnutrition, Nutritional assessment, Pediatric, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 5 Oct 2026 (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.
This cross-sectional study aims to determine the prevalence and pattern of malnutrition (acute wasting, chronic stunting, and micronutrient deficiency) among children with cardiomyopathy attending the Pediatric Cardiology Unit at Assiut University Children's Hospital.
Detailed description
Cardiomyopathy in children encompasses a heterogeneous group of primary myocardial disorders (dilated, hypertrophic, and restrictive) that represent a leading cause of chronic heart failure and a common indication for heart transplantation in the pediatric age group.
Malnutrition is now recognized as a common and clinically significant comorbidity in pediatric cardiomyopathy. Data from the Pediatric Cardiomyopathy Registry indicate that nearly a quarter of children with dilated cardiomyopathy are malnourished at presentation, while pooled estimates from adult heart failure populations report a malnutrition prevalence approaching half of all patients, with malnutrition independently associated with increased mortality.
This cross-sectional study will include children aged 1 month to 18 years with an established diagnosis of cardiomyopathy confirmed by echocardiography. Nutritional status will be assessed using anthropometric measurements (weight, height, MUAC, BMI-for-age z-scores), the STRONGkids screening tool, biochemical markers, and dietary assessment. The prevalence and pattern of malnutrition will be determined.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Cardiomyopathy | – | –Children aged 1 month to 18 years with an established diagnosis of cardiomyopathy (dilated, hypertrophic, or restrictive) confirmed by echocardiography, attending or admitted to the Pediatric Cardiology Unit at Assiut University Children's Hospital. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 1 month to 18 years with an established diagnosis of cardiomyopathy (dilated, hypertrophic, or restrictive) confirmed by echocardiography, attending or admitted to the Pediatric Cardiology Unit at Assiut University Children's Hospital.
Key inclusion criteria (4 listed)
- Children aged 1 month to 18 years.
- Established diagnosis of cardiomyopathy (dilated, hypertrophic, or restrictive) confirmed by echocardiography.
- Attending or admitted to the Pediatric Cardiology Unit at Assiut University Children's Hospital.
- Written informed consent from parent/legal guardian.
Key exclusion criteria (3 listed)
- Known chronic conditions with an independent, primary effect on nutritional status (e.g., celiac disease, chronic kidney disease, malignancy).
- Genetic/metabolic syndromes with intrinsic growth failure unrelated to cardiac status.
- Refusal of parental/guardian informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Title: Prevalence of malnutrition
Time frame: Baseline
Proportion of children with cardiomyopathy who have malnutrition based on anthropometric z-scores according to WHO growth standards.
5 secondary outcomes
Proportion of children at nutritional risk by STRONGkids
Time frame: Baseline
Mean left ventricular ejection fraction
Time frame: Baseline
Mean serum albumin
Time frame: Baseline
Mean body mass index for age z-score
Time frame: Baseline
Proportion of children with feeding difficulties
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Gamal A Asker, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Malnutrition, 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 4 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manar Abd El-Aziz, Resident (01019138170, Manarabdelaziz057@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Title: Prevalence of malnutrition (time frame: Baseline). 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 5 Oct 2026.