Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers (STBETA)
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|ClinicalTrials.gov Identifier: NCT02104011|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Angiomyolipomas Tuberous Sclerosis||Drug: Propranolol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial|
|Actual Study Start Date :||May 22, 2015|
|Actual Primary Completion Date :||November 22, 2017|
|Actual Study Completion Date :||November 22, 2017|
U.S. FDA Resources
|Experimental: Patient||Drug: Propranolol|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104011
|Principal Investigator:||Claire RIGOTHIER, Dr||UH Bordeaux|