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

This study has been terminated.
(Inability to recruit patients into the study.)
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Ofelia Alvarez, University of Miami
ClinicalTrials.gov Identifier:
NCT02012777
First received: December 6, 2013
Last updated: June 6, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Sickle Cell Disease Drug: propranolol Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Propanolol Effect on Red Cell Adhesion in Non-Asthmatic Children With Sickle Cell Disease: A Dose Finding Study

Resource links provided by NLM:


Further study details as provided by Ofelia Alvarez, University of Miami:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 9
Study Start Date: June 2010
Study Completion Date: April 3, 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012777

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Duke University
Investigators
Principal Investigator: Ofelia A Alvarez, MD University of Miami
  More Information

Publications:
Chang, MW. Journal Watch Dermatology. Nov 6, 2009 Propanolol for Infantile Hemangioma: Safety Issues and Proposed Protocol

Responsible Party: Ofelia Alvarez, Professor of Clinical Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT02012777     History of Changes
Other Study ID Numbers: 20100334
Study First Received: December 6, 2013
Last Updated: June 6, 2017
Individual Participant Data  
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:
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

ClinicalTrials.gov processed this record on June 23, 2017