Sickle Cell DiseaseNCT02394431
Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Cardiac echography, Biological parameters and Clinical parameters
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Jun 2016
- 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: Sickle cell disease patients
Who may be able to join
- All sickle cell disease patients
Who cannot join
- Insufficient echogenicity
Trial locations and contacts
1 site in 1 country.
About this study
Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation.
Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages.
Read more
The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed the existence of a dysfunction.
Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the cardiac function, independent of the blood volume. This technique hasn't been used much in sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a higher global longitudinal strain in this patient population. The investigators find these data hard to explain and in contradiction with previous studies using other cardiac function evaluation techniques, independent from the blood volume.
The primary goal of this study is thus
- to study the longitudinal strain by 2D echography
- to determine if anomalies of the longitudinal strain exist in sickle cell disease patients with a normal ejected left ventricular fraction, compared to a control group of healthy patients.
The secondary goal of this study is to correlate, inside the sickle cell disease group, the possible strain anomalies with biological gravity parameters of the disease.
- Conditions
- Sickle Cell Disease
- Being tested
- Cardiac echography, Biological parameters, Clinical parameters
- Keywords
- Sickle Cell Disease, Echocardiography, Speckle tracking
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac echographyOther
Ejection fraction measured by Teicholz and planimetry, diastolic function, tissular doppler, myocardiac performance index, global longitudinal strain measured by speckle tracking, arterial pulmonary hypertension, left ventricular hypertrophy.
Biological parametersOther
Hemoglobin levels, red cells, hematocrit, iron, ferritin
Clinical parametersOther
Blood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness
| Study group | Role | What they receive |
|---|---|---|
| Sickle cell disease patients | Sickle cell disease patients Receives: Other: Cardiac echography; Other: Biological parameters; Other: Clinical parameters | |
| Healthy patients | This is the control group for the sickle cell disease patients: each sickle cell disease patient will be matched with a healthy patient of the same sex and of similar age. Receives: Other: Cardiac echography; Other: Biological parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac ejection fraction
Ejection fraction measured by Teicholz and planimety.
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Cardiac diastolic function
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Cardiac tissular doppler
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Myocardiac performance index
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Global longitudinal strain
Global longitudinal strain measured by speckle tracking.
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
arterial pulmonary hypertension
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
left ventricular hypertrophy
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Secondary outcomes (7)
Biological parameters: hemoglobin levels
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: ferritin levels
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: red cells count
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: hematocrit levels
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: iron levels
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Clinical parameters: severity of the illness
Sickle cell disease organ damages.
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Clinical parameters: sanguine transfusion numbers
Measured: once per year, at the annual medical visit planned according to the standart of care for this pathology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Marielle Morissens, Brugmann University Hospital
- Investigators
- Marielle MORISSENS, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394431
- Sponsor's protocol ID
- CHUB-Echo-Cardio
- Status last verified
- Jul 2016
- First submitted
- 10 Mar 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahmad H, Gayat E, Yodwut C, Abduch MC, Patel AR, Weinert L, Desai A, Tsang W, Garcia JG, Lang RM, Mor-Avi V. Evaluation of myocardial deformation in patients with sickle cell disease and preserved ejection fraction using three-dimensional speckle tracking echocardiography. Echocardiography. 2012 Sep;29(8):962-9. doi: 10.1111/j.1540-8175.2012.01710.x. Epub 2012 May 8.
PubMed 22563937Knight-Perry JE, de las Fuentes L, Waggoner AD, Hoffmann RG, Blinder MA, Davila-Roman VG, Field JJ. Abnormalities in cardiac structure and function in adults with sickle cell disease are not associated with pulmonary hypertension. J Am Soc Echocardiogr. 2011 Nov;24(11):1285-90. doi: 10.1016/j.echo.2011.07.009. Epub 2011 Aug 27.
PubMed 21873028Sachdev V, Machado RF, Shizukuda Y, Rao YN, Sidenko S, Ernst I, St Peter M, Coles WA, Rosing DR, Blackwelder WC, Castro O, Kato GJ, Gladwin MT. Diastolic dysfunction is an independent risk factor for death in patients with sickle cell disease. J Am Coll Cardiol. 2007 Jan 30;49(4):472-9. doi: 10.1016/j.jacc.2006.09.038. Epub 2007 Jan 16.
PubMed 17258093Hankins JS, McCarville MB, Hillenbrand CM, Loeffler RB, Ware RE, Song R, Smeltzer MP, Joshi V. Ventricular diastolic dysfunction in sickle cell anemia is common but not associated with myocardial iron deposition. Pediatr Blood Cancer. 2010 Sep;55(3):495-500. doi: 10.1002/pbc.22587.
PubMed 20658621Voskaridou E, Christoulas D, Terpos E. Sickle-cell disease and the heart: review of the current literature. Br J Haematol. 2012 Jun;157(6):664-73. doi: 10.1111/j.1365-2141.2012.09143.x. Epub 2012 Apr 25.
PubMed 22530942Poludasu S, Ramkissoon K, Salciccioli L, Kamran H, Lazar JM. Left ventricular systolic function in sickle cell anemia: a meta-analysis. J Card Fail. 2013 May;19(5):333-41. doi: 10.1016/j.cardfail.2013.03.009.
PubMed 23663816
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02394431
- Acronym / sponsor ID
- CHUB-Echo-Cardio
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Echocardiography, Speckle tracking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- 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.
Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation.
Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages.
The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed the existence of a dysfunction.
Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the cardiac function, independent of the blood volume. This technique hasn't been used much in sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a higher global longitudinal strain in this patient population. The investigators find these data hard to explain and in contradiction with previous studies using other cardiac function evaluation techniques, independent from the blood volume.
The primary goal of this study is thus
- to study the longitudinal strain by 2D echography
- to determine if anomalies of the longitudinal strain exist in sickle cell disease patients with a normal ejected left ventricular fraction, compared to a control group of healthy patients.
The secondary goal of this study is to correlate, inside the sickle cell disease group, the possible strain anomalies with biological gravity parameters of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sickle cell disease patients | – | Other: Cardiac echography, Other: Biological parameters, Other: Clinical parametersSickle cell disease patients |
| Healthy patients | – | Other: Cardiac echography, Other: Biological parametersThis is the control group for the sickle cell disease patients: each sickle cell disease patient will be matched with a healthy patient of the same sex and of similar age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sickle cell disease patients
Key inclusion criteria (1 listed)
- All sickle cell disease patients
Key exclusion criteria (1 listed)
- Insufficient echogenicity
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 |
|---|---|---|
| Cardiac echographyEjection fraction measured by Teicholz and planimetry, diastolic function, tissular doppler, myocardiac performance index, global longitudinal strain measured by speckle tracking, arterial pulmonary hypertension, left ventricular hypertrophy. | Other | Healthy patients, Sickle cell disease patients |
| Biological parametersHemoglobin levels, red cells, hematocrit, iron, ferritin | Other | Healthy patients, Sickle cell disease patients |
| Clinical parametersBlood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness | Other | Sickle cell disease patients |
Primary outcome
Cardiac ejection fraction
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Ejection fraction measured by Teicholz and planimety.
Cardiac diastolic function
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Cardiac tissular doppler
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Myocardiac performance index
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Global longitudinal strain
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Global longitudinal strain measured by speckle tracking.
arterial pulmonary hypertension
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
left ventricular hypertrophy
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
7 secondary outcomes
Biological parameters: hemoglobin levels
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: ferritin levels
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: red cells count
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: hematocrit levels
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Biological parameters: iron levels
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Clinical parameters: severity of the illness
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
Clinical parameters: sanguine transfusion numbers
Time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology
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 26 Jul 2016.
- Background: PubMed 22563937Ahmad H, Gayat E, Yodwut C, Abduch MC, Patel AR, Weinert L, Desai A, Tsang W, Garcia JG, Lang RM, Mor-Avi V. Evaluation of myocardial deformation in patients with sickle cell disease and preserved ejection fraction using three-dimensional speckle tracking echocardiography. Echocardiography. 2012 Sep;29(8):962-9. doi: 10.1111/j.1540-8175.2012.01710.x. Epub 2012 May 8.
- Background: PubMed 21873028Knight-Perry JE, de las Fuentes L, Waggoner AD, Hoffmann RG, Blinder MA, Davila-Roman VG, Field JJ. Abnormalities in cardiac structure and function in adults with sickle cell disease are not associated with pulmonary hypertension. J Am Soc Echocardiogr. 2011 Nov;24(11):1285-90. doi: 10.1016/j.echo.2011.07.009. Epub 2011 Aug 27.
- Background: PubMed 17258093Sachdev V, Machado RF, Shizukuda Y, Rao YN, Sidenko S, Ernst I, St Peter M, Coles WA, Rosing DR, Blackwelder WC, Castro O, Kato GJ, Gladwin MT. Diastolic dysfunction is an independent risk factor for death in patients with sickle cell disease. J Am Coll Cardiol. 2007 Jan 30;49(4):472-9. doi: 10.1016/j.jacc.2006.09.038. Epub 2007 Jan 16.
- Background: PubMed 20658621Hankins JS, McCarville MB, Hillenbrand CM, Loeffler RB, Ware RE, Song R, Smeltzer MP, Joshi V. Ventricular diastolic dysfunction in sickle cell anemia is common but not associated with myocardial iron deposition. Pediatr Blood Cancer. 2010 Sep;55(3):495-500. doi: 10.1002/pbc.22587.
- Background: PubMed 22530942Voskaridou E, Christoulas D, Terpos E. Sickle-cell disease and the heart: review of the current literature. Br J Haematol. 2012 Jun;157(6):664-73. doi: 10.1111/j.1365-2141.2012.09143.x. Epub 2012 Apr 25.
- Background: PubMed 23663816Poludasu S, Ramkissoon K, Salciccioli L, Kamran H, Lazar JM. Left ventricular systolic function in sickle cell anemia: a meta-analysis. J Card Fail. 2013 May;19(5):333-41. doi: 10.1016/j.cardfail.2013.03.009.
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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.
Marielle MORISSENS, MD principal investigator
CHU Brugmann
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 Sickle Cell Disease, run by Brugmann University Hospital at 1 site in Belgium.
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 1 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 26 Jul 2016. 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 Belgium. 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?
Cardiac ejection fraction (time frame: once per year, at the annual medical visit planned according to the standart of care for this pathology). The study lists 7 primary outcomes in all. 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 NCT02394431, which also lists 6 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 26 Jul 2016.