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TerminatedNCT02104011STBETAUpdated Jun 24, 2026

Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers

A Phase 2 interventional study of Propranolol in Renal Angiomyolipomas and Tuberous Sclerosis, sponsored by University Hospital, Bordeaux. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment

Why this study was terminated
target number of subject not reached
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Renal Angiomyolipomas
  • Tuberous Sclerosis

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Keywords

  • Angiomyolipomas in tuberous sclerosis
  • Beta-blockers
  • Anti-angiogenic therapies
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In context

Tuberous Sclerosis

115 studies on the registry are indexed under Tuberous Sclerosis; 27 are open to participants now.

This study's enrollment of 2 is below the median of 52 across 73 interventional studies indexed under Tuberous Sclerosis.

Browse Tuberous Sclerosis studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.
  • Diabetic subjects insufficiently controlled.
  • Beta-blockers .
  • Psychosis, severe mental disorder.
  • Patient already treated with beta-blockers or mTOR inhibitors.
  • Pregnant or nursing women.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Patient

    Drug: Propranolol

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months and 1 year after inclusion

Secondary outcomes

  1. Renal function evolution

    Improvement of renal function after 6 months and 1 year of treatment

    Time frame: 6 months and 1 year after inclusion

  2. Effect on the potential haemorraghic transformation

    Haemorraghic transformation of angiomyolipomas is diagnosed by Scanner or MRI.

    Time frame: 6 months and 1 year after inclusion

  3. Improvement of the quality of life

    Th evolution of the quality of life is assessed by an EVA scale and by QOL scale.

    Time frame: 6 months and 1 year after inclusion.

  4. Effect on face angiofibromas

    Evolution of the face angiofibromas by a dermatologic assessment.

    Time frame: 6 months and 1 year after inclusion

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Study locations

1 site
  • Nephrology department
    Bordeaux, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02104011
Responsible party
Sponsor
First posted
Apr 4, 2014
Start date
May 22, 2015
Primary completion
Nov 22, 2017
Completion
Nov 22, 2017
Last update
Jun 24, 2026

Study contacts

Claire RIGOTHIER, Dr
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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