Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers

Tuberous Sclerosis Clinical Trial

— STBETA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104011
• Other study ID #: CHUBX 2011/35
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2014
• Last updated: January 19, 2018
• Start date: May 22, 2015
• Est. completion date: November 22, 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 22, 2017
• Est. primary completion date: November 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tuberous sclerosis patients with one or several angiomyolipomas of a size of at least 4 cms.

Exclusion Criteria:

• Patients whom CT or MR scan shows one or several intra-lesional aneurisms requiring a preventive embolization.

• Patients with a retroperitoneal hemorragic complication requiring a preventive embolization.

• Patients whom biopsy will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.

• Diabetic subjects insufficiently controlled.

• Beta-blockers contra-indication.

• Psychosis, severe mental disorder.

• Patient already treated with beta-blockers or mTOR inhibitors.

• Pregnant or nursing women.

Related Conditions & MeSH terms

• Angiomyolipoma
• Renal Angiomyolipomas
• Sclerosis
• Tuberous Sclerosis

Intervention

Drug:
• Propranolol

Locations

Country	Name	City	State
France	Nephrology department	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of angiomyolipomas volume	Stabilization or even regression of angiomyolipomas volume after 6 months and 1 year of treatment with a quantification of the vascular component.	6 months and 1 year after inclusion
Secondary	Renal function evolution	Improvement of renal function after 6 months and 1 year of treatment	6 months and 1 year after inclusion
Secondary	Effect on the potential haemorraghic transformation	Haemorraghic transformation of angiomyolipomas is diagnosed by Scanner or MRI.	6 months and 1 year after inclusion
Secondary	Improvement of the quality of life	Th evolution of the quality of life is assessed by an EVA scale and by QOL scale.	6 months and 1 year after inclusion.
Secondary	Effect on face angiofibromas	Evolution of the face angiofibromas by a dermatologic assessment.	6 months and 1 year after inclusion