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

June 6, 2017 updated by: Ofelia Alvarez, University of Miami

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Inderal
  • Inderal LA
  • InnoPran XL
  • propanolol systemic
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:
  • Inderal
  • Inderal LA
  • InnoPran XL
  • propanolol systemic
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:
  • Inderal
  • Inderal LA
  • InnoPran XL
  • propanolol systemic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 24 hours after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Duke University

Investigators

  • Principal Investigator: Ofelia A Alvarez, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

April 3, 2013

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20100334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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