Chronic Renal DiseaseSPECKLEKIDNEYNCT04897672
2D-speckle Tracking in Pediatric Renal Chronic Disease
An observational study of Chronic Renal Disease and Chronic Renal Insufficiency, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The SPECKLE- KIDNEY-PED is a multicentre observational controlled trial aiming to evaluate the 2D-Speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Disease, Chronic Renal Insufficiency, Congenital Heart Disease
- What is being tested?
- Observational study
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 30 Dec 2021
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cases group : Children aged 6 to 17years old with chronic renal insufficiency Control group: Children aged 6 to 17 years old with normal check up
Who may be able to join
- Patient aged 6 to 17 years old
- Patient with chronic renal disease (>3 months)
- Patient with renal insufficiency (glomerular filtration rate < 80ml/min/1,73m2)
Who cannot join
- Patient with associated congenital heart disease
- Patient with uncontrolled arrythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of 2D-Speckle Tracking Echocardiography in a Pediatric Population With Chronic Renal Disease: a Multicentre Cross-sectional Controlled Study (SPECKLE-KIDNEY-PED)
The SPECKLE- KIDNEY-PED is a multicentre observational controlled trial aiming to evaluate the 2D-Speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. The secondary objective is to assess the conventional echocardiographic parameters and the level of exercice capacity.
Read the detailed description
Kidney disease and chronic kidney failure are one of the most common causes of chronic childhood disease. They are often complicated by cardiovascular disease, which can, in the long run, affect patients' prognosis. Thus, mortality in children undergoing hemodialysis for end-stage kidney failure is related in more than 30% of cases to a cardiovascular complication. An annual cardiac assessment is recommended as part of the follow-up of these patients to assess the cardiac impact of kidney disease (high blood pressure, hyper-uremia, etc.). The use of conventional cardiological assessment parameters does not predict the cardiovascular prognosis of patients because the alteration of these parameters is greatly delayed in the course of the disease. 2D strain or "speckle tracking echocardiography" is a non-invasive ultrasound technique that allows for a more sensitive assessment of myocardial tissue damage and its early impairment has been shown as a factor of poor prognosis in other pediatric chronic pathology (neuromuscular disease, cardiotoxic exposure, etc.) as well as in adult chronic kidney failure.
The SPECKLE- KIDNEY-PED trial is a multicentre observationnal controlled study. The main objective of this work is to asses the 2D strain ventricular function in children with kidney failure, to compare it with that of healthy children of 6 to 17 years old, and to correlate it with the cardio-renal severity of the disease in terms of level of kidney failure and aerobic physical fitness.
The secondary objective is to assess, in this population, the level of exercice capacity and to compare it to the general population of children of the same age.
A total of 180 children are recquired to observe a significant difference of 2,5% of the global strain value with a power of 90% and an alpha risk of 5%.
The SPECKLE- KIDNEY-PED trial intends to improve the level of evidence for future guidelines on cardiologic survey and promotion of physical activity in this population
- Being tested
- Observational study
- Keywords
- Speckle-tracking, Exercice capacity, Cardiovascular prognosis
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| case | case: Children aged 6 to 17 years old reffered to the pediatric cardiology consultation with a chronic renal disease and renal insufficiency Receives: Other: Observational study | |
| control | control : Children aged 6 to 17 years old reffered to the pediatric cardiology consultation who were classified in the control group after a completely normal check-up, including physical examination, electrocardiogram, and echocardiography Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global and segmentary longitudinal 2D- speckle tracking value of the left ventricule by transthoracic echocardiography
Transthoracic echocardiography parameters
Measured: Baseline (1day)
Secondary outcomes (2)
Conventional echocardiography parameters
ransthoracic echocardiography parameters
Measured: Baseline (1day)
Exercice capacity
Cardiopulmonary exercice test with VO2max assessment
Measured: Baseline (1day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 May 2021
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
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 Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Toulouse, University Hospital, Bordeaux, University Hospital, Limoges, Marseille University Hospital- La Timone, Hopital Universitaire Robert-Debre
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD-PhD, Study director, UH MONTPELLIEROscar WERNER, MD, Principal investigator, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897672
- Sponsor's protocol ID
- RECHMPL21_0344
- Acronym
- SPECKLEKIDNEY
- Status last verified
- Jan 2022
- First submitted
- 18 May 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Werner O, Fila M, Herman F, Audie M, Harambat J, Llanas B, Morin D, Djouadi N, Matecki S, Guillaumont S, Vincenti M, De La Villeon G, Pommier V, Roussey G, Prigent S, Baruteau AE, Abassi H, Andrianoely M, Tenenbaum J, Gavotto A, Desir A, Batterton MK, Picot MC, Amedro P; QUALIREHAB study group. Early and Stage-Dependent Cardiopulmonary Fitness Impairment in Pediatric CKD. Clin J Am Soc Nephrol. 2026 Jul 22. doi: 10.2215/CJN.0000001113. Online ahead of print.
PubMed 42485103
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 2D-Speckle Tracking Echocardiography in a Pediatric Population With Chronic Renal Disease: a Multicentre Cross-sectional Controlled Study (SPECKLE-KIDNEY-PED)
- ClinicalTrials.gov ID
- NCT04897672
- Acronym / sponsor ID
- SPECKLEKIDNEY / RECHMPL21_0344
- Keywords
- Speckle-tracking, Exercice capacity, Cardiovascular prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Toulouse, University Hospital, Bordeaux, University Hospital, Limoges, Marseille University Hospital- La Timone, Hopital Universitaire Robert-Debre
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 21 May 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 SPECKLE- KIDNEY-PED is a multicentre observational controlled trial aiming to evaluate the 2D-Speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. The secondary objective is to assess the conventional echocardiographic parameters and the level of exercice capacity.
Detailed description
Kidney disease and chronic kidney failure are one of the most common causes of chronic childhood disease. They are often complicated by cardiovascular disease, which can, in the long run, affect patients' prognosis. Thus, mortality in children undergoing hemodialysis for end-stage kidney failure is related in more than 30% of cases to a cardiovascular complication. An annual cardiac assessment is recommended as part of the follow-up of these patients to assess the cardiac impact of kidney disease (high blood pressure, hyper-uremia, etc.). The use of conventional cardiological assessment parameters does not predict the cardiovascular prognosis of patients because the alteration of these parameters is greatly delayed in the course of the disease. 2D strain or "speckle tracking echocardiography" is a non-invasive ultrasound technique that allows for a more sensitive assessment of myocardial tissue damage and its early impairment has been shown as a factor of poor prognosis in other pediatric chronic pathology (neuromuscular disease, cardiotoxic exposure, etc.) as well as in adult chronic kidney failure.
The SPECKLE- KIDNEY-PED trial is a multicentre observationnal controlled study. The main objective of this work is to asses the 2D strain ventricular function in children with kidney failure, to compare it with that of healthy children of 6 to 17 years old, and to correlate it with the cardio-renal severity of the disease in terms of level of kidney failure and aerobic physical fitness.
The secondary objective is to assess, in this population, the level of exercice capacity and to compare it to the general population of children of the same age.
A total of 180 children are recquired to observe a significant difference of 2,5% of the global strain value with a power of 90% and an alpha risk of 5%.
The SPECKLE- KIDNEY-PED trial intends to improve the level of evidence for future guidelines on cardiologic survey and promotion of physical activity in this population
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Other: Observational studycase: Children aged 6 to 17 years old reffered to the pediatric cardiology consultation with a chronic renal disease and renal insufficiency |
| control | – | Other: Observational studycontrol : Children aged 6 to 17 years old reffered to the pediatric cardiology consultation who were classified in the control group after a completely normal check-up, including physical examination, electrocardiogram, and echocardiography |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cases group : Children aged 6 to 17years old with chronic renal insufficiency Control group: Children aged 6 to 17 years old with normal check up
Key inclusion criteria (3 listed)
- Patient aged 6 to 17 years old
- Patient with chronic renal disease (>3 months)
- Patient with renal insufficiency (glomerular filtration rate < 80ml/min/1,73m2)
Key exclusion criteria (2 listed)
- Patient with associated congenital heart disease
- Patient with uncontrolled arrythmia
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 |
|---|---|---|
| Observational studyObservational study | Other | case, control |
Primary outcome
Global and segmentary longitudinal 2D- speckle tracking value of the left ventricule by transthoracic echocardiography
Time frame: Baseline (1day)
Transthoracic echocardiography parameters
2 secondary outcomes
Conventional echocardiography parameters
Time frame: Baseline (1day)
Exercice capacity
Time frame: Baseline (1day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 42485103Werner O, Fila M, Herman F, Audie M, Harambat J, Llanas B, Morin D, Djouadi N, Matecki S, Guillaumont S, Vincenti M, De La Villeon G, Pommier V, Roussey G, Prigent S, Baruteau AE, Abassi H, Andrianoely M, Tenenbaum J, Gavotto A, Desir A, Batterton MK, Picot MC, Amedro P; QUALIREHAB study group. Early and Stage-Dependent Cardiopulmonary Fitness Impairment in Pediatric CKD. Clin J Am Soc Nephrol. 2026 Jul 22. doi: 10.2215/CJN.0000001113. Online ahead of print.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pascal AMEDRO, MD-PhD study director
UH MONTPELLIER
Oscar WERNER, MD principal investigator
UH MONTPELLIER
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 Chronic Renal Disease and Chronic Renal Insufficiency, run by University Hospital, Montpellier at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global and segmentary longitudinal 2D- speckle tracking value of the left ventricule by transthoracic echocardiography (time frame: Baseline (1day)). 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 NCT04897672, 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 11 Jan 2022.