Clinical Trial: Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers

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

Official Title: Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial

Brief Summary:

Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.

The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.


Detailed Summary:
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Evolution of angiomyolipomas volume [ Time Frame: 6 months and 1 year after inclusion ]

Stabilization or even regression of angiomyolipomas volume after 6 months and 1 year of treatment with a quantification of the vascular component.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Renal function evolution [ Time Frame: 6 months and 1 year after inclusion ]
    Improvement of renal function after 6 months and 1 year of treatment
  • Effect on the potential haemorraghic transformation [ Time Frame: 6 months and 1 year after inclusion ]
    Haemorraghic transformation of angiomyolipomas is diagnosed by Scanner or MRI.
  • Improvement of the quality of life [ Time Frame: 6 months and 1 year after inclusion. ]
    Th evolution of the quality of life is assessed by an EVA scale and by QOL scale.
  • Effect on face angiofibromas [ Time Frame: 6 months and 1 year after inclusion ]
    Evolution of the face angiofibromas by a dermatologic assessment.


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: April 1, 2014
Date Started: May 2015
Date Completion: April 2017
Last Updated: June 12, 2015
Last Verified: June 2015