Analyze the Results of Cardiorespiratory Stress TestsPHYSIO-EXDRENCT06743139
Exploration of the Parameters Influencing the Effort Limitation of Patients Suffering From Homozygous Sickle Cell Anemia
An observational study of Analyze the Results of Cardiorespiratory Stress Tests and Resting and Stress Echocardiography, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analyze the Results of Cardiorespiratory Stress Tests, Resting and Stress Echocardiography, Capillary Lactatemia Measurements at the Ear
- What is being tested?
- Echography
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2021to 11 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with homozygous sickle cell disease
Who may be able to join
- Adult patient ≥ 18 years old
- Affiliated with a social security scheme (beneficiary or beneficiary's beneficiary)
Who cannot join
- Pregnant or breast-feeding women
- Patients under guardianship, curatorship or legal protection
- Patient under AME
- Patient with a contraindication or unsuitability for physical activity on a cycloergometer
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
Créteil, Paris, 94010
About this study
Official title: Evaluation of Effort Limitation Parameters of Patients With Homozygous Sickle Cell Disease
The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients..
Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.
It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.
Read the detailed description
The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients.
Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.
It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.
- Conditions
- Analyze the Results of Cardiorespiratory Stress Tests, Resting and Stress Echocardiography, Capillary Lactatemia Measurements at the Ear
- Being tested
- Echography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchographyDiagnostic test
Simultaneous performance of an echocardiogram (part of the follow-up assessment for sickle cell heart disease) at rest and then during the cardiorespiratory stress test, and an ear capillary lactatemia analysis (already routinely performed to ensure the safety of the cardiorespiratory stress test) during the cardiorespiratory stress test routinely performed at Mondor University Hospital prior to cardiovascular rehabilitation programs.
What is being measured
The primary outcome is the main question the study is designed to answer.
To define different clinico-biological profiles in patients with sickle cell disease (HbSS)
To define different clinico-biological profiles in patients with sickle cell disease (HbSS) by means of an exhaustive physiological analysis coupled with exercise.
Measured: 4 weeks
Secondary outcomes (1)
Study resting characteristics to identify at an early stage patients with potential cardiac alterations.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start10 Mar 2021
- Primary completion10 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Analyze the Results of Cardiorespiratory Stress TestsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas D'HUMIERES, Dr, Study director, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743139
- Sponsor's protocol ID
- APHP201322
- Acronym
- PHYSIO-EXDRE
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Les données sont la propriété de l'APHP
Publications
Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
PubMed 23877260http://beh.santepubliquefrance.fr/beh/2015/8/2015_8_2.html
Fitzhugh CD, Lauder N, Jonassaint JC, Telen MJ, Zhao X, Wright EC, Gilliam FR, De Castro LM. Cardiopulmonary complications leading to premature deaths in adult patients with sickle cell disease. Am J Hematol. 2010 Jan;85(1):36-40. doi: 10.1002/ajh.21569.
PubMed 20029950Hammoudi N, Lionnet F, Redheuil A, Montalescot G. Cardiovascular manifestations of sickle cell disease. Eur Heart J. 2020 Apr 1;41(13):1365-1373. doi: 10.1093/eurheartj/ehz217.
PubMed 31005979Guazzi M, Bandera F, Ozemek C, Systrom D, Arena R. Cardiopulmonary Exercise Testing: What Is its Value? J Am Coll Cardiol. 2017 Sep 26;70(13):1618-1636. doi: 10.1016/j.jacc.2017.08.012.
PubMed 28935040
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effort Limitation Parameters of Patients With Homozygous Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06743139
- Acronym / sponsor ID
- PHYSIO-EXDRE / APHP201322
- Conditions
- Analyze the Results of Cardiorespiratory Stress Tests, Resting and Stress Echocardiography, Capillary Lactatemia Measurements at the Ear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 19 Dec 2024 (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 cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients..
Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.
It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.
Detailed description
The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients.
Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.
It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with homozygous sickle cell disease
Key inclusion criteria (2 listed)
- Adult patient ≥ 18 years old
- Affiliated with a social security scheme (beneficiary or beneficiary's beneficiary)
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding women
- Patients under guardianship, curatorship or legal protection
- Patient under AME
- Patient with a contraindication or unsuitability for physical activity on a cycloergometer
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 |
|---|---|---|
| EchographySimultaneous performance of an echocardiogram (part of the follow-up assessment for sickle cell heart disease) at rest and then during the cardiorespiratory stress test, and an ear capillary lactatemia analysis (already routinely performed to ensure the safety of the cardiorespiratory stress test) during the cardiorespiratory stress test routinely performed at Mondor University Hospital prior to cardiovascular rehabilitation programs. | Diagnostic test | – |
Primary outcome
To define different clinico-biological profiles in patients with sickle cell disease (HbSS)
Time frame: 4 weeks
To define different clinico-biological profiles in patients with sickle cell disease (HbSS) by means of an exhaustive physiological analysis coupled with exercise.
1 secondary outcome
Study resting characteristics to identify at an early stage patients with potential cardiac alterations.
Time frame: 4 weeks
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 19 Dec 2024.
- Background: PubMed 23877260Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
- Backgroundhttp://beh.santepubliquefrance.fr/beh/2015/8/2015_8_2.html
- Background: PubMed 20029950Fitzhugh CD, Lauder N, Jonassaint JC, Telen MJ, Zhao X, Wright EC, Gilliam FR, De Castro LM. Cardiopulmonary complications leading to premature deaths in adult patients with sickle cell disease. Am J Hematol. 2010 Jan;85(1):36-40. doi: 10.1002/ajh.21569.
- Background: PubMed 31005979Hammoudi N, Lionnet F, Redheuil A, Montalescot G. Cardiovascular manifestations of sickle cell disease. Eur Heart J. 2020 Apr 1;41(13):1365-1373. doi: 10.1093/eurheartj/ehz217.
- Background: PubMed 28935040Guazzi M, Bandera F, Ozemek C, Systrom D, Arena R. Cardiopulmonary Exercise Testing: What Is its Value? J Am Coll Cardiol. 2017 Sep 26;70(13):1618-1636. doi: 10.1016/j.jacc.2017.08.012.
- Individual participant dataSharing planned: No. Les données sont la propriété de l'APHP
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.
Thomas D'HUMIERES, Dr study director
Henri Mondor University Hospital
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 Analyze the Results of Cardiorespiratory Stress Tests and Resting and Stress Echocardiography, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 4 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 19 Dec 2024. 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?
To define different clinico-biological profiles in patients with sickle cell disease (HbSS) (time frame: 4 weeks). 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 NCT06743139, which also lists 5 linked publications.
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 19 Dec 2024.