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Propanolol and Red Cell Adhesion Non-asthmatic Children Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02012777
Recruitment Status : Terminated (Inability to recruit patients into the study.)
First Posted : December 16, 2013
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Ofelia Alvarez, University of Miami

Study Description
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Brief Summary:
Propanolol is a beta blocker which has been found to inhibit the ability of epinephrine to upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose of this pilot study is to administer one dose of propanolol to children with sickle cell disease and to measure pre and post dose red cell adhesion. The hypothesis is that a single dose of propanolol will decrease red cell adhesion to laminin and endothelial cells as compared to baseline.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: propranolol Phase 1

Detailed Description:
A similar pilot study has already been conducted in adults and is now being tried in children to gather preliminary data for a grant submission. No safety issues were found in the adult pilot study. This study will evaluate the effect of different doses of propanolol. The risks of this study involve the risks of three (3) blood draws and the risks of propanolol. In order to minimize the risks children with sickle cell disease and asthma will be excluded because asthma is a contraindication to the use of propanolol. In addition, patients will not be hypertensive or bradycardic.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Propanolol Effect on Red Cell Adhesion in Non-Asthmatic Children With Sickle Cell Disease: A Dose Finding Study
Study Start Date : June 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : April 3, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: cohort 1 10mg propranolol

first study arm will consist of 5 subjects who will be administered a dose of 10mg propanolol and followed 1-4 weeks.

Data safety and monitoring committee has reviewed the data for safety and instructed the study to continue based on the findings.

 Drug: propranolol
Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent. This will be administered in an open-label single administration to 3 cohorts (10mg, 20mg, and 40mg) of children with sickle cell disease. Patient blood will be evaluated for red cell adhesion and patient data evaluated for safety monitoring.
Other Names:
  • propanolol systemic
  • Inderal
  • Inderal LA
  • InnoPran XL
Active Comparator: cohort 2 20mg propranolol
This cohort will involve the administration of 5 subjects with 20mg propanolol. The data safety and monitoring committee will review the data for safety when the 5 subjects are recruited and instruct the study to continue depending on the findings.
 Drug: propranolol
Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent. This will be administered in an open-label single administration to 3 cohorts (10mg, 20mg, and 40mg) of children with sickle cell disease. Patient blood will be evaluated for red cell adhesion and patient data evaluated for safety monitoring.
Other Names:
  • propanolol systemic
  • Inderal
  • Inderal LA
  • InnoPran XL
Active Comparator: cohort 3 40mg propranolol
This cohort will involve the administration of 10 subjects with 40mg propanolol. The data safety and monitoring committee will review the data for safety when the 10 subjects are recruited and instruct the study to continue depending on the findings.
 Drug: propranolol
Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent. This will be administered in an open-label single administration to 3 cohorts (10mg, 20mg, and 40mg) of children with sickle cell disease. Patient blood will be evaluated for red cell adhesion and patient data evaluated for safety monitoring.
Other Names:
  • propanolol systemic
  • Inderal
  • Inderal LA
  • InnoPran XL


Outcome Measures
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Primary Outcome Measures :
  1. measurement of the sickle red cell response to epinephrine [ Time Frame: 1-4 weeks ]
    At study initiation 5mL of blood is drawn to evaluate for red cell adhesion (screening visit or visit 1). At the intervention visit 1-4 weeks later another 5mL of blood will be drawn and patient will have an ECG performed, followed by one dose of propanolol at the stratum that s/he is in. Vitals signs will be monitored (including blood pressure) for 4 hours after drug administration.


Secondary Outcome Measures :
  1. Safety data regarding the use of propanolol in children with sickle cell disease [ Time Frame: within 24 hours after drug administration ]
    1. New onset wheezing
    2. Onset of low blood pressure defined as blood pressure less than 90/50
    3. Onset of heart rate less than 60 beats/min


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of HbSS or HbSBeta0Thal
  2. age 10-17 years
  3. Weight 30kg or greater
  4. Hb 7mg/dL or greater
  5. informed consent

Exclusion Criteria:

  1. History of vaso-occlusive crisis during the past 6 weeks, or history of transfusion during the past 3 months.
  2. pregnancy
  3. history of heart failure, myocardial infarction, asthma, bradyarrythmias, hypotension, thyroid disease, diabetes, renal insufficiency
  4. concurrent medications: any antihypertensive medication, diuretics, thyroid replacement medications, any arrythmia medication, insulin, hypoglycaemic medication
  5. history of allergy to sulfonamides
  6. elevated BUN or creatinine
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): NCT02012777


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Duke University
Investigators
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Principal Investigator: Ofelia A Alvarez, MD University of Miami
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Chang, MW. Journal Watch Dermatology. Nov 6, 2009 Propanolol for Infantile Hemangioma: Safety Issues and Proposed Protocol

Other Publications:

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Responsible Party: Ofelia Alvarez, Professor of Clinical Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT02012777    
Other Study ID Numbers: 20100334
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ofelia Alvarez, University of Miami:
sickle cell disease
propanolol
red blood cell adhesion
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Tissue Adhesions
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Cicatrix
Fibrosis
Pathologic Processes
 Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents