Clinical Trial: The Oxford Marfan Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised, Double-blind, Placebo-controlled Pilot Trial of Irbesartan, Doxycycline and a Combination on Markers of Vascular Dysfunction in the Marfan Syndrome, Using Ca

Brief Summary: The primary objective of the trial is to estimate the effects of allocation to irbesartan, or doxycycline, or a combination of both irbesartan and doxycycline, compared with placebo, on measures of elastic function of the aorta in people with the Marfan syndrome and enlargement of the aorta.

Detailed Summary:
Sponsor: University of Oxford

Current Primary Outcome: Change (i.e. difference between first and last study visits) in aortic distensibility in the ascending aorta between allocation arms measured using CMR [ Time Frame: 0 months and 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 1. Change in aortic distensibility in the proximal and distal descending aorta between allocation arms measured using CMR [ Time Frame: 0 and 6 months ]
  • 2. Change in aortic dimensions in the proximal and distal descending aorta [ Time Frame: 0 and 6 months ]
  • 3. Change in mean and peak axial and mean and peak circumferential aortic wall shear stress between allocation arms estimated by CMR using a 4D flow sequence [ Time Frame: 0 and 6 months ]
  • 4. Change in peripheral (brachial) blood pressure between allocation arms measured using a calibrated, validated automated sphygmomanometer [ Time Frame: 0 and 6 months ]
  • 5. Change in central blood pressure, and augmentation index between allocation arms measured by applanation tonometry and by oscillometric sphygmomanometry [ Time Frame: 0 and 6 months ]
  • 6. Change in left ventricular volumes, mass and systolic function between allocation arms to placebo measured by CMR [ Time Frame: 0 and 6 months ]
  • 7. Change in aortic pulse wave velocity between allocation arms measured by CMR [ Time Frame: 0 and 6 months ]
  • 8. Change in carotid-femoral pulse wave velocity between allocation arms compared to placebo measured by applanation tonometry [ Time Frame: 0 and 6 months ]
  • 9. Change in TGF-β level, or other biomarker, between allocation arms compared to placebo [ Time Frame: 0 and 6 months ]
  • 10. Tolerability and safety of irbesartan and doxycycline, assessed by incidence of adverse reactions and change in health status score, using the SF-36 questionnaire [ Time Frame: 0, 0.5 and 6 months ]
  • 11. Document the frequency of aortic dissection, death from cardiovascular causes, or need for aortic root or valve surgery (if any) in each allocation arm [ Time Frame: 0-6 months ]


Original Secondary Outcome: Same as current

Information By: University of Oxford

Dates:
Date Received: August 6, 2013
Date Started: October 2013
Date Completion: December 2017
Last Updated: June 8, 2015
Last Verified: June 2015