Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-22

Study Completion Date

2017-11-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Angiomyolipomas Tuberous Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Interventions

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Propranolol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No