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