Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

• Status: Unknown status
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Propranolol

Criteria

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.