Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

St. Joseph's Hospital and Medical Center, Phoenix

Status and phase: Terminated; Phase 2

Conditions: Cerebral Cavernous Malformations

Treatments: Drug: Propranolol; Genetic: DNA and RNA Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03474614

17-0173-30-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

4 participants in 2 patient groups

treatment group

Experimental group

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.

Treatment:

Drug: Propranolol

Genetic: DNA and RNA Analysis

Control Group

Other group

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.

Treatment:

Genetic: DNA and RNA Analysis