Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394431
• Other study ID #: CHUB-Echo-Cardio
• Status: Completed
• Phase: N/A
• First received: March 10, 2015
• Last updated: July 25, 2016
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All sickle cell disease patients

Exclusion Criteria:

• Insufficient echogenicity

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• Cardiac echography
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 parameters
Hemoglobin levels, red cells, hematocrit, iron, ferritin
• Clinical parameters
Blood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View Citation

Hankins 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. — View Citation

Knight-Perry JE, de Las Fuentes L, Waggoner AD, Hoffmann RG, Blinder MA, Dávila-Román 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. — View Citation

Poludasu 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. Review. — View Citation

Sachdev 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. Epub 2007 Jan 16. — View Citation

Voskaridou 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac ejection fraction	Ejection fraction measured by Teicholz and planimety.	once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Primary	Cardiac diastolic function		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Primary	Cardiac tissular doppler		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Primary	Myocardiac performance index		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Primary	Global longitudinal strain	Global longitudinal strain measured by speckle tracking.	once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Primary	arterial pulmonary hypertension		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Primary	left ventricular hypertrophy		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Secondary	Biological parameters: hemoglobin levels		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Secondary	Biological parameters: ferritin levels		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Secondary	Biological parameters: red cells count		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Secondary	Biological parameters: hematocrit levels		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Secondary	Biological parameters: iron levels		once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Secondary	Clinical parameters: severity of the illness	Sickle cell disease organ damages.	once per year, at the annual medical visit planned according to the standart of care for this pathology	No
Secondary	Clinical parameters: sanguine transfusion numbers		once per year, at the annual medical visit planned according to the standart of care for this pathology	No