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

Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sickle Cell Disease

Intervention: propranolol (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Miami

Official(s) and/or principal investigator(s):
Ofelia A Alvarez, MD, Principal Investigator, Affiliation: University of Miami

Overall contact:
Ofelia Alvarez, MD, Phone: 305.243.0846, Email: oalvarez2@med.miami.edu


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.

Clinical Details

Official title: Propanolol Effect on Red Cell Adhesion in Non-Asthmatic Children With Sickle Cell Disease: A Dose Finding Study

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: measurement of the sickle red cell response to epinephrine

Secondary outcome: Safety data regarding the use of propanolol in children with sickle cell disease

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.


Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.


Inclusion Criteria: 1. diagnosis of HbSS or HbSBeta0Thal 2. age 7-17 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

Locations and Contacts

Ofelia Alvarez, MD, Phone: 305.243.0846, Email: oalvarez2@med.miami.edu

University of Miami, Miami, Florida 33136, United States; Recruiting
Ofelia Alvarez, MD, Phone: 305-243-0846, Email: oalvarez2@med.miami.edu
Tally Hustace, ARNP, Phone: 305.243.6924, Email: thustace@med.miami.edu
Ofelia Alvarez, MD, Principal Investigator
Additional Information

Related publications:

Storch CH, Hoeger PH. Propranolol for infantile haemangiomas: insights into the molecular mechanisms of action. Br J Dermatol. 2010 Aug;163(2):269-74. doi: 10.1111/j.1365-2133.2010.09848.x. Epub 2010 May 8. Review.

Starting date: June 2010
Last updated: May 20, 2015

Page last updated: August 23, 2015

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