Back to resultsEffect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation
Primary Purpose
Cerebral Cavernous Malformations
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol
DNA and RNA Analysis
Sponsored by
About this trial
This is an interventional other trial for Cerebral Cavernous Malformations
Eligibility Criteria
Inclusion Criteria:
- Subject is at least 18-years of age.
- Clinical and imaging diagnosis of a symptomatic Isolated cavernous malformation or Familial cavernous malformation
- MRI Imaging Grade Type I or Type II (see Table 1)
- Patient is considered a candidate for surgical resection of their cavernous malformation
- Written and informed consent obtained prior to the study enrollment.
- Negative pregnancy test at time of enrollment for women of child-bearing potential.
- Heart rate greater than 50 beats per minute
- Systolic blood pressure > 90 mmHg
Exclusion Criteria:
- Subject is less than 18-years of age.
- History of allergy to propranolol or other beta blockers.
- Patient is already taking another beta blocker for cardiac indications.
- History of asthma presently requiring any active treatment (oral medications or inhalers).
- History of cardiac dysfunction (as defined by the New York Heart Association Functional Classification grade II, III or IV).
- Heart rate < 50 beats per minute
- Systolic blood pressure < 90 mmHg
- History of diabetes and currently on any anti-hyperglycemic medication.
- Pregnant and lactating women.
Sites / Locations
- Barrow Neurological Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
treatment group
Control Group
Arm Description
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.
A control group of 10 (n=10) patients will receive only their routine medications (no propranolol) during the (-7 to -10 days) preoperative period. A control group (n=10) is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.
Outcomes
Primary Outcome Measures
To measure effects of low-dose oral propranolol on global messenger RNA (mRNA) and microRNA (miRNA) expression in the blood and tissue of patients with CCM
compare changes noted in mRNA and miRNA in blood and CCM tissue samples of patients who do and do not receive propranolol preoperatively for CCM
Secondary Outcome Measures
To correlate treatment response to propranolol with the underlying established mutations in cerebral cavernous malformation (CCM) genes.
correlate and compare genetic mutations seen in CCM genes in tissue of patients who receive propranolol preoperatively
Record adverse event (tolerance to) related to low-dose oral propranolol (60mg ER once daily)
Number of reported adverse events in patients taking propranolol
Full Information
NCT ID
NCT03474614
First Posted
March 5, 2018
Last Updated
October 25, 2019
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
1. Study Identification
Unique Protocol Identification Number
NCT03474614
Brief Title
Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation
Official Title
Effect of Oral Propranolol on mRNA Expression in Symptomatice Caavernous Malformation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
January 24, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Cavernous Malformations
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two groups, intervention and control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
A control group of 10 (n=10) patients will receive only their routine medications (no propranolol) during the (-7 to -10 days) preoperative period. A control group (n=10) is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
The medication will be administered so that patient receives a minimum of 7- days and maximum of 10-days of treatment with propranolol prior to planned surgical resection of CCM (routine care)
Intervention Type
Genetic
Intervention Name(s)
DNA and RNA Analysis
Intervention Description
During the operative procedure, a small sample of the patient's blood will be obtained and small (1 to 2cc) tissue sample from the resected cavernous malformation will be collected. The blood and tissue samples will be labeled and stored for subsequent DNA and RNA analysis
Primary Outcome Measure Information:
Title
To measure effects of low-dose oral propranolol on global messenger RNA (mRNA) and microRNA (miRNA) expression in the blood and tissue of patients with CCM
Description
compare changes noted in mRNA and miRNA in blood and CCM tissue samples of patients who do and do not receive propranolol preoperatively for CCM
Time Frame
-7 to -10 days until surgery
Secondary Outcome Measure Information:
Title
To correlate treatment response to propranolol with the underlying established mutations in cerebral cavernous malformation (CCM) genes.
Description
correlate and compare genetic mutations seen in CCM genes in tissue of patients who receive propranolol preoperatively
Time Frame
-7 to -10 days until surgery
Title
Record adverse event (tolerance to) related to low-dose oral propranolol (60mg ER once daily)
Description
Number of reported adverse events in patients taking propranolol
Time Frame
-7 to -10 days until surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is at least 18-years of age.
Clinical and imaging diagnosis of a symptomatic Isolated cavernous malformation or Familial cavernous malformation
MRI Imaging Grade Type I or Type II (see Table 1)
Patient is considered a candidate for surgical resection of their cavernous malformation
Written and informed consent obtained prior to the study enrollment.
Negative pregnancy test at time of enrollment for women of child-bearing potential.
Heart rate greater than 50 beats per minute
Systolic blood pressure > 90 mmHg
Exclusion Criteria:
Subject is less than 18-years of age.
History of allergy to propranolol or other beta blockers.
Patient is already taking another beta blocker for cardiac indications.
History of asthma presently requiring any active treatment (oral medications or inhalers).
History of cardiac dysfunction (as defined by the New York Heart Association Functional Classification grade II, III or IV).
Heart rate < 50 beats per minute
Systolic blood pressure < 90 mmHg
History of diabetes and currently on any anti-hyperglycemic medication.
Pregnant and lactating women.
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation
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