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Trial record 6 of 11 for:    Cavernous Malformation

Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

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ClinicalTrials.gov Identifier: NCT03474614
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Norissa Honea, St. Joseph's Hospital and Medical Center, Phoenix

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE January 24, 2018
Estimated Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
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 [ Time Frame: -7 to -10 days until surgery ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • To correlate treatment response to propranolol with the underlying established mutations in cerebral cavernous malformation (CCM) genes. [ Time Frame: -7 to -10 days until surgery ]
    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) [ Time Frame: -7 to -10 days until surgery ]
    Number of reported adverse events in patients taking propranolol
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two groups, intervention and control
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cerebral Cavernous Malformations
Intervention  ICMJE
  • Drug: 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)
  • Genetic: 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
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Propranolol
    • Genetic: 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.
    Intervention: Genetic: DNA and RNA Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dignity Health project leader 602-406-6267 Norissa.Honea@dignityhealth.org
Contact: Steev Mallon, BSN, RN 602-406-4217 Steev.Mallon@dignityhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03474614
Other Study ID Numbers  ICMJE 17-0173-30-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Norissa Honea, St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor  ICMJE St. Joseph's Hospital and Medical Center, Phoenix
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP