Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers (STBETA)

May 18, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Nephrology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient
Drug: Propranolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months and 1 year after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function evolution
Time Frame: 6 months and 1 year after inclusion
Improvement of renal function after 6 months and 1 year of treatment
6 months and 1 year after inclusion
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.
6 months and 1 year after inclusion
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.
6 months and 1 year after inclusion.
Effect on face angiofibromas
Time Frame: 6 months and 1 year after inclusion
Evolution of the face angiofibromas by a dermatologic assessment.
6 months and 1 year after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Claire RIGOTHIER, Dr, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2015

Primary Completion (Actual)

November 22, 2017

Study Completion (Actual)

November 22, 2017

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimated)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2011/35
  • 2013-003477-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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