Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 To correlate treatment response to propranolol with the underlying established mutations in cerebral cavernous malformation (CCM) genes.

Condition

Cerebral Cavernous Malformations

Intervention

Propranolol

Study Arms / Comparison Groups

 treatment 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

January 24, 2018

Completion Date

August 30, 2020

Primary Completion Date

January 24, 2020

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03474614

Organization ID

17-0173-30-12


Responsible Party

Principal Investigator

Study Sponsor

St. Joseph's Hospital and Medical Center, Phoenix


Study Sponsor

, , 


Verification Date

October 2019