Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

NCT ID: NCT03474614

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2021-02-11

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.

Conditions

Cerebral Cavernous Malformations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

treatment group

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.

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

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)

DNA and RNA Analysis

Intervention Type: GENETIC

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

Control Group

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.

Group Type: OTHER

DNA and RNA Analysis

Intervention Type: GENETIC

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

Interventions

Propranolol

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: DRUG

DNA and RNA Analysis

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

Intervention Type: GENETIC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role: lead

Responsible Party

Lori Wood

Research Operations Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Zabramski, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Brain and Spine

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

17-0173-30-12

Identifier Type: -

Identifier Source: org_study_id