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Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation | Clinical Trials | Clareo Health

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Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

Effect of Oral Propranolol on mRNA Expression in Symptomatice Caavernous Malformation

NCT03474614•St. Joseph's Hospital and Medical Center, Phoenix

Summary

This is a single center, randomized, trial that will enroll twenty (n=20) patients with a diagnosis of symptomatic cavernous malformations who are planned candidates for surgical resection by one of the investigators, and who meet all of the inclusion and exclusion criteria. Patients will be randomized into two groups: A Treatment group of ten (n=10) patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule per day) for 7- to 10-days prior to surgery plus their usual medications, and a Control group of 10 (n=10) patients will receive only their routine medications. Currently, the only active treatment alternative for symptomatic cerebral cavernous malformations is surgery. A control group is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.

Detailed Description

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is at least 18-years of age.
•2. Clinical and imaging diagnosis of a symptomatic Isolated cavernous malformation or Familial cavernous malformation
•3. MRI Imaging Grade Type I or Type II (see Table 1)
•4. Patient is considered a candidate for surgical resection of their cavernous malformation
•5. Written and informed consent obtained prior to the study enrollment.
•6. Negative pregnancy test at time of enrollment for women of child-bearing potential.
•7. Heart rate greater than 50 beats per minute
•8. Systolic blood pressure \> 90 mmHg

Exclusion Criteria

•1. Subject is less than 18-years of age.
•2. History of allergy to propranolol or other beta blockers.
•3. Patient is already taking another beta blocker for cardiac indications.
•4. History of asthma presently requiring any active treatment (oral medications or inhalers).
•5. History of cardiac dysfunction (as defined by the New York Heart Association Functional Classification grade II, III or IV).
•6. Heart rate \< 50 beats per minute
•7. Systolic blood pressure \< 90 mmHg
•8. History of diabetes and currently on any anti-hyperglycemic medication.
•9. Pregnant and lactating women.

Locations (1)

Barrow Neurological Institute

Phoenix, Arizona, United States

Key Dates

Start Date

January 24, 2018

Primary Completion Date

February 11, 2021

Completion Date

February 11, 2021

Last Updated

April 19, 2024

Enrollment

ACTUAL participants

Conditions

Cerebral Cavernous Malformations

Interventions

Propranolol

DRUG

DNA and RNA Analysis

GENETIC

Modifiers of Disease Severity in Cerebral Cavernous Malformations

NCT01764529

Cavernous Angioma, FamilialCerebral Cavernous Malformations+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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