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

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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

Tracking Information
First Submitted Date  ICMJE December 6, 2013
First Posted Date  ICMJE December 16, 2013
Last Update Posted Date June 8, 2017
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propanolol and Red Cell Adhesion Non-asthmatic Children Sickle Cell Disease
Official Title  ICMJE Propanolol Effect on Red Cell Adhesion in Non-Asthmatic Children With Sickle Cell Disease: A Dose Finding Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.

    Intervention: Drug: propranolol
  • 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.
    Intervention: Drug: propranolol
  • 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.
    Intervention: Drug: propranolol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 6, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2013)
20
Actual Study Completion Date  ICMJE April 3, 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02012777
Other Study ID Numbers  ICMJE 20100334
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ofelia Alvarez, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Duke University
Investigators  ICMJE
Principal Investigator: Ofelia A Alvarez, MD University of Miami
PRS Account University of Miami
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP