Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02104011
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Renal Angiomyolipomas Tuberous Sclerosis Drug: Propranolol Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Patient Drug: Propranolol

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Renal function evolution [ Time Frame: 6 months and 1 year after inclusion ]
    Improvement of renal function after 6 months and 1 year of treatment

  2. 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.

  3. 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.

  4. Effect on face angiofibromas [ Time Frame: 6 months and 1 year after inclusion ]
    Evolution of the face angiofibromas by a dermatologic assessment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02104011

Layout table for location information
Nephrology department
Bordeaux, France
Sponsors and Collaborators
University Hospital, Bordeaux
Layout table for investigator information
Principal Investigator: Claire RIGOTHIER, Dr UH Bordeaux

Layout table for additonal information
Responsible Party: University Hospital, Bordeaux Identifier: NCT02104011     History of Changes
Other Study ID Numbers: CHUBX 2011/35
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by University Hospital, Bordeaux:
Angiomyolipomas in tuberous sclerosis
Anti-angiogenic therapies
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberous Sclerosis
Pathologic Processes
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Perivascular Epithelioid Cell Neoplasms
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents