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

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ClinicalTrials.gov Identifier: NCT02394431
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Marielle Morissens, Brugmann University Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Sickle Cell Disease Other: Cardiac echography Other: Biological parameters Other: Clinical parameters

Study Design
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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Sickle cell disease patients
Sickle cell disease patients
 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.

Other: Biological parameters
Hemoglobin levels, red cells, hematocrit, iron, ferritin

Other: Clinical parameters
Blood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness
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.
 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.

Other: Biological parameters
Hemoglobin levels, red cells, hematocrit, iron, ferritin


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Cardiac diastolic function [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  3. Cardiac tissular doppler [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  4. Myocardiac performance index [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  5. 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.

  6. arterial pulmonary hypertension [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  7. left ventricular hypertrophy [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]

Secondary Outcome Measures :
  1. Biological parameters: hemoglobin levels [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  2. Biological parameters: ferritin levels [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  3. 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 ]
  4. Biological parameters: hematocrit levels [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  5. Biological parameters: iron levels [ Time Frame: once per year, at the annual medical visit planned according to the standart of care for this pathology ]
  6. 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 ]
    Sickle cell disease organ damages.

  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sickle cell disease patients
Criteria

Inclusion Criteria:

  • All sickle cell disease patients

Exclusion Criteria:

  • Insufficient echogenicity
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394431


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Marielle MORISSENS, MD CHU Brugmann
More Information
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Publications:

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Responsible Party: Dr Marielle Morissens, Deputy Head of Clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02394431    
Other Study ID Numbers: CHUB-Echo-Cardio
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by Dr Marielle Morissens, Brugmann University Hospital:
Sickle Cell Disease
Echocardiography
Speckle tracking
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn