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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
Sponsor:
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

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT02104011


Locations
France
Nephrology department
Bordeaux, France
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Claire RIGOTHIER, Dr UH Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov 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
Beta-blockers
Anti-angiogenic therapies

Additional relevant MeSH terms:
Sclerosis
Tuberous Sclerosis
Angiomyolipoma
Pathologic Processes
Hamartoma
Neoplasms
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
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents