Zinc DeficiencyNCT04860921
Zinc Deficiency in Dilated Cardiomyopathy
An observational study of Zinc Deficiency, run by Assiut University.
Trial summary
The aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Zinc Deficiency
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2021to 28 Dec 2022
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patiente between 1 and18 years with dilated cardiomypathy
Who may be able to join
- children (1-18) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy
Who cannot join
- patients with congenital heart diseases.
- patients less than one year age.
Trial locations and contacts
No sites are listed yet.
Safaa Sholkamy contact
About this study
Official title: Oral Zinc Supplementation in Children With Dilated Cardiomyopathy : Aprospective Cohort Study in Assiut ,Egypt.
The aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy.
Read the detailed description
Cardiomyopathies are group of heart diseases that influence cardiac muscles directly and are not related to hypertension, congenital, valvular and pericardial diseases. The most common type of cardiomyopathy is dilate cardiomyopathy.
Dilated cardiomyopathy usually manifests as chronic systolic heart failure leading to arrhythmias and sudden death.
Trace elements are known to have a key role in myocardial metabolism. The human heart requires energy from micro and macro nutrients both to regenerate proteins and cells, and to support cyclic contractions. Heart failure is associated with neuro-hormonal activation leading to elevated levels of inflammatory markers and oxidative stress.
Zinc is an essential micronutrient that impacts the cardiovascular system. There are multiple potential pathophysiologic causes for zinc deficiency in heart failure as result of impaired micronutrient consumption, hyper inflammatory state, diminished absorption and hyperzincuria from heart failure medications. Zinc deficiency may play a role as primary and possible reversible cause of dilated cardiomyopathy.
Plasma zinc levels have been reported in multiple observational studies of patients with heart failure particularly in studies of idiopathic dilated cardiomyopathy, serum zinc levels have been found to be low.
A small but growing body of evidence suggesting the role for oral zinc supplementation in the management of dilated cardiomyopathy however further evaluation of the impact on outcome is needed.
- Conditions
- Zinc Deficiency
- Keywords
- Dilated cardiomopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
New york heart associaton functional classification for grading heart failure
All cases included the study will be carefully examined for sings of heart failure according to new york heart association classification for grading of heart failure
Measured: 1.5 year
Secondary outcomes (1)
Detailed echocardiographic examination
Detailed echocardiography using Phillips Envisor C according to the guidelines of the American society of echocardiography(18)،focusing on follow up of left ventricle end diastolic dimension Z-score ,left ventricle fractional shortening and ejection fraction.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start20 Apr 2021 (estimated)
- Primary completion20 Nov 2022 (estimated)
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zinc DeficiencyStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Abdel Hameed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860921
- Sponsor's protocol ID
- Zinc in dilated cardiomyopathy
- Status last verified
- Apr 2021
- First submitted
- 17 Nov 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maron BJ, Towbin JA, Thiene G, Antzelevitch C, Corrado D, Arnett D, Moss AJ, Seidman CE, Young JB; American Heart Association; Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; Council on Epidemiology and Prevention. Contemporary definitions and classification of the cardiomyopathies: an American Heart Association Scientific Statement from the Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; and Council on Epidemiology and Prevention. Circulation. 2006 Apr 11;113(14):1807-16. doi: 10.1161/CIRCULATIONAHA.106.174287. Epub 2006 Mar 27.
PubMed 16567565
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Zinc Supplementation in Children With Dilated Cardiomyopathy : Aprospective Cohort Study in Assiut ,Egypt.
- ClinicalTrials.gov ID
- NCT04860921
- Acronym / sponsor ID
- Zinc in dilated cardiomyopathy
- Conditions
- Zinc Deficiency
- Keywords
- Dilated cardiomopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (estimated)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 27 Apr 2021 (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.
The aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy.
Detailed description
Cardiomyopathies are group of heart diseases that influence cardiac muscles directly and are not related to hypertension, congenital, valvular and pericardial diseases. The most common type of cardiomyopathy is dilate cardiomyopathy.
Dilated cardiomyopathy usually manifests as chronic systolic heart failure leading to arrhythmias and sudden death.
Trace elements are known to have a key role in myocardial metabolism. The human heart requires energy from micro and macro nutrients both to regenerate proteins and cells, and to support cyclic contractions. Heart failure is associated with neuro-hormonal activation leading to elevated levels of inflammatory markers and oxidative stress.
Zinc is an essential micronutrient that impacts the cardiovascular system. There are multiple potential pathophysiologic causes for zinc deficiency in heart failure as result of impaired micronutrient consumption, hyper inflammatory state, diminished absorption and hyperzincuria from heart failure medications. Zinc deficiency may play a role as primary and possible reversible cause of dilated cardiomyopathy.
Plasma zinc levels have been reported in multiple observational studies of patients with heart failure particularly in studies of idiopathic dilated cardiomyopathy, serum zinc levels have been found to be low.
A small but growing body of evidence suggesting the role for oral zinc supplementation in the management of dilated cardiomyopathy however further evaluation of the impact on outcome is needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patiente between 1 and18 years with dilated cardiomypathy
Key inclusion criteria (1 listed)
- children (1-18) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy
Key exclusion criteria (2 listed)
- patients with congenital heart diseases.
- patients less than one year age.
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
New york heart associaton functional classification for grading heart failure
Time frame: 1.5 year
All cases included the study will be carefully examined for sings of heart failure according to new york heart association classification for grading of heart failure
1 secondary outcome
Detailed echocardiographic examination
Time frame: 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 16567565Maron BJ, Towbin JA, Thiene G, Antzelevitch C, Corrado D, Arnett D, Moss AJ, Seidman CE, Young JB; American Heart Association; Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; Council on Epidemiology and Prevention. Contemporary definitions and classification of the cardiomyopathies: an American Heart Association Scientific Statement from the Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; and Council on Epidemiology and Prevention. Circulation. 2006 Apr 11;113(14):1807-16. doi: 10.1161/CIRCULATIONAHA.106.174287. Epub 2006 Mar 27.
- Individual participant dataSharing planned: Undecided
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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.
Safaa Sholkamy contact
Questions about this trial
What is this clinical trial studying?
An observational study of Zinc Deficiency, 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 2 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 27 Apr 2021. 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 Safaa Ahmed (01096449446, Safaa.20124126@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New york heart associaton functional classification for grading heart failure (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860921, which also lists 1 linked publication.
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 27 Apr 2021.