CardiomyopathiesPRO-OMICSNCT04670731
Ventricular Remodelling and Metabolomics in Pediatric Cardiomyopathies (PROGRESS-OMICS)
An observational study of Cardiomyopathies and Pediatric ALL, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
The pathogenesis of cardiomyopathies is complex and a simple approach cannot describe the whole picture. Different etiologies are reported in pediatric age and heart failure onset can lead to poor prognosis in term of need of heart transplantation and ventricular assist device implantation. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies, Pediatric ALL
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2021to Jun 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 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study population will include all children (< 18 years) presenting with dilated cardiomyopathy
Who may be able to join
- Dilated Cardiomyopathy, defined as left ventricular dilation > 2SD
- A-D stages of Heart Failure, according to ACC/AHA definition
- < 18 years
- Children without familial disease and/ or abnormalities of ECG and echocardiographic, NT pro BNP ≥ 103 pg/mL, TnT ≥ 14
Who cannot join
- Restrictive cardiomyopathy
- Hypertrophic cardiomyopathy
- Congenital Heart Diasease
- Valvular Heart Disease, as primary cause of heart failure
- > 18 years
- Control Group
- Children with familial disease and/or any abnormalities of ECG and echocardiographic abnormalities, NT pro BNP ≥ 103 pg/mL, TnT ≥ 14
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Ventricular Remodelling and Metabolomics in Pediatric Cardiomyopathies (PROGRESS-OMICS)
The pathogenesis of cardiomyopathies is complex and a simple approach cannot describe the whole picture. Different etiologies are reported in pediatric age and heart failure onset can lead to poor prognosis in term of need of heart transplantation and ventricular assist device implantation. Based on hypothesis that heart failure development is related to heart inability to meet metabolic demands of the body, our study will focus to evaluate cardiac metabolism as one of the most critical factors and the accompanying changes of metabolic and echocardiographic profiles at different stages of heart failure. The heart is a unique organ working continuously as a pump supplying blood to the body. To meet this requirement, the myocardium utilizes fatty acids to generate 70-90% of the adenosine triphospate, with the rest being produced by oxidation of glucose, lactate, ketone bodies, aminoacids. Utilization of fatty acids is reduced in the failing heart and there is a metabolic shift to generation of adenosine triphospate from glucose. In patients with advanced cardiomyopathies, the heart is unable to utilize either metabolite and thus "runs out of fuel". It is reported that the adenosine triphospate level is approximately 30% lower in failing human hearts compared with non-failing hearts. In addition to this premise about the metabolic profile of the failing heart, recent advances in the field of metabolomics have indicated that several metabolites and/or metabolic pathways have a role in heart failure. Metabolism of lipids, glycolysis, fructolysis, aminoacids, and ketone oxidation have been found to be altered in non-ischemic cardiomyopathy in adult population. Also in adult heart failure patients some metabolic profiles resulted pronounced perturbated. Taking advantage of the high throughput, metabolomics is a platform for identifying metabolic signatures in children at each stages of heart failure (from pre clinical heart failure to end stage forms). We also will determine whether metabolomic analysis provides sensitive evaluation of heart failure in terms of remodelling at different stages and in disease regression after therapeutic interventions. Study desing is conceived in two parts. The first part is retrospective and we will analyze all echocardiograms in all children affected by cardiomyopathies. The second part is a cross sectional study in which will evaluate untargeted metabolomics in children at any stage of heart failure (A,B, C, D) and in control group. We will evaluate the clinical applicability and significance of plasma metabolomic analysis in the diagnosis and prognosis of heart failure in pediatric ages.
- Conditions
- Cardiomyopathies, Pediatric ALL
- Medical subject headings
- Cardiomyopathies, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of untargeted metabolomic profiles
Identification of metabolomic profiles in children with heart failure according to different stages od heart failure (A, predisposing condition; B- asymptomatic stage; C- symptomatic; D: end stage) and control group
Measured: 1 year
Secondary outcomes (3)
metabolomic profile and ventricular remodelling
correlation between metabolomic profiles and echocardiographic characteristic, such as left ventricular mass, left ventricular dilatation, mass/volume ratio) according to different stages of heart failure (A, predisposing condition; B- asymptomatic stage; C- symptomatic; D: end stage)
Measured: 1 year
metabolomic profile and ventricular remodelling
correlation between metabolomic profiles and ECG characteristics, such as duration of PR, QRS, T wave change, according to different stages of heart failure (A, predisposing condition; B- asymptomatic stage; C- symptomatic; D: end stage)
Measured: 1 year
identification of potential diagnostic of metabolomic profile
correlation between metabolomic profiles and clinical outcome, such as clinical stage, progression of remolling, death, heart transplantion, acute hospitalization for heart failure, VAD implantation, heart transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startFeb 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (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.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Parent Project, Italy, Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Rachele Adorisio, MD, Study chair, Bambino Gesù Hospital and Research Institute, Rome, ItalyRachele Adorisio, MD, Principal investigator, Bambino Gesù Hospital and Research Institute, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670731
- Sponsor's protocol ID
- 2259
- Acronym
- PRO-OMICS
- Status last verified
- Nov 2020
- First submitted
- 10 Dec 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ventricular Remodelling and Metabolomics in Pediatric Cardiomyopathies (PROGRESS-OMICS)
- ClinicalTrials.gov ID
- NCT04670731
- Acronym / sponsor ID
- PRO-OMICS / 2259
- Conditions
- Cardiomyopathies, Pediatric ALL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- Parent Project, Italy, Ministry of Health, Italy
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 17 Dec 2020 (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 pathogenesis of cardiomyopathies is complex and a simple approach cannot describe the whole picture. Different etiologies are reported in pediatric age and heart failure onset can lead to poor prognosis in term of need of heart transplantation and ventricular assist device implantation. Based on hypothesis that heart failure development is related to heart inability to meet metabolic demands of the body, our study will focus to evaluate cardiac metabolism as one of the most critical factors and the accompanying changes of metabolic and echocardiographic profiles at different stages of heart failure. The heart is a unique organ working continuously as a pump supplying blood to the body. To meet this requirement, the myocardium utilizes fatty acids to generate 70-90% of the adenosine triphospate, with the rest being produced by oxidation of glucose, lactate, ketone bodies, aminoacids. Utilization of fatty acids is reduced in the failing heart and there is a metabolic shift to generation of adenosine triphospate from glucose. In patients with advanced cardiomyopathies, the heart is unable to utilize either metabolite and thus "runs out of fuel". It is reported that the adenosine triphospate level is approximately 30% lower in failing human hearts compared with non-failing hearts. In addition to this premise about the metabolic profile of the failing heart, recent advances in the field of metabolomics have indicated that several metabolites and/or metabolic pathways have a role in heart failure. Metabolism of lipids, glycolysis, fructolysis, aminoacids, and ketone oxidation have been found to be altered in non-ischemic cardiomyopathy in adult population. Also in adult heart failure patients some metabolic profiles resulted pronounced perturbated. Taking advantage of the high throughput, metabolomics is a platform for identifying metabolic signatures in children at each stages of heart failure (from pre clinical heart failure to end stage forms). We also will determine whether metabolomic analysis provides sensitive evaluation of heart failure in terms of remodelling at different stages and in disease regression after therapeutic interventions. Study desing is conceived in two parts. The first part is retrospective and we will analyze all echocardiograms in all children affected by cardiomyopathies. The second part is a cross sectional study in which will evaluate untargeted metabolomics in children at any stage of heart failure (A,B, C, D) and in control group. We will evaluate the clinical applicability and significance of plasma metabolomic analysis in the diagnosis and prognosis of heart failure in pediatric ages.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population will include all children (< 18 years) presenting with dilated cardiomyopathy
Key inclusion criteria (4 listed)
- Dilated Cardiomyopathy, defined as left ventricular dilation > 2SD
- A-D stages of Heart Failure, according to ACC/AHA definition
- < 18 years
- Children without familial disease and/ or abnormalities of ECG and echocardiographic, NT pro BNP ≥ 103 pg/mL, TnT ≥ 14
Key exclusion criteria (7 listed)
- Restrictive cardiomyopathy
- Hypertrophic cardiomyopathy
- Congenital Heart Diasease
- Valvular Heart Disease, as primary cause of heart failure
- > 18 years
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
Identification of untargeted metabolomic profiles
Time frame: 1 year
Identification of metabolomic profiles in children with heart failure according to different stages od heart failure (A, predisposing condition; B- asymptomatic stage; C- symptomatic; D: end stage) and control group
3 secondary outcomes
metabolomic profile and ventricular remodelling
Time frame: 1 year
metabolomic profile and ventricular remodelling
Time frame: 1 year
identification of potential diagnostic of metabolomic profile
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
Rachele Adorisio, MD study chair
Bambino Gesù Hospital and Research Institute, Rome, Italy
Rachele Adorisio, MD principal investigator
Bambino Gesù Hospital and Research Institute, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Pediatric ALL, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 7 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of untargeted metabolomic profiles (time frame: 1 year). 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 Feb 2021.