A Phase 3 interventional study of Propranolol treatment and Placebo in Hereditary Hemorrhagic Telangiectasia and Osler Weber Rendu Disease, sponsored by University Hospital, Bordeaux. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
Hereditary Hemorrhagic Telangiectasia (HHT) is a genetic disorder of angiogenesis associated with disabling epistaxis. Management of these nose bleedings requires more effective treatment. Propranolol, a beta-blocker, is a potentially useful therapeutic considering its anti-angiogenic properties. Our objective is to explore the efficacy of propranolol, three months after its introduction, on the cumulative duration of epistaxis in HHT patients.
Hereditary Hemorrhagic Telangiectasia (HHT) is a rare systemic autosomal dominantly inherited disorder of angiogenesis. Its major feature is the occurrence in 90% of patients of spontaneous and recurrent epistaxis responsible for iron deficiency and chronic anemia. Various conservative and interventional treatments have been described for these conditions, but no optimal therapy exists. Inhibiting angiogenesis process is an interesting therapeutic option. Propranolol, a non-cardio-selective beta-blocker, could represent a new candidate for the therapy of HHT telangiectasia as it suppresses angiogenesis in vitro. This anti-angiogenic property is well-known in pediatric dermatology, since C. Léauté-Labrèze and al. have demonstrated a great improvement of infantile hemangioma undergoing propranolol treatment. At the University Hospital Center of Bordeaux, the investigators assessed in a preliminary study the efficacy of propranolol for HHT epistaxis. Nine of ten patients receiving propranolol for cardiologic or neurologic indications, retrospectively analyzed, significantly improved their Epistaxis Severity Score. Ten patients were then prospectively included and after 3 months of propranolol treatment, the median duration of epistaxis per month significantly decreased (p=0,007) as well as the number of epistaxis episodes per month (p=0,015).
To confirm these results, the investigators would like to study the efficacy of propranolol given per os at the dose of 40 mg twice a day for a three-months period, in comparison to a placebo. Throughout the study, patients will complete specific grids recording the number of epistaxis episodes per month and the cumulative duration of nose bleedings. A follow-up of 6 months will be done (4 visits after inclusion), recording clinical and biological data and monitoring the tolerance of treatment.
106 studies on the registry are indexed under Telangiectasia, Hereditary Hemorrhagic; 24 are open to participants now.
This study's enrollment of 15 is below the median of 33 across 61 interventional studies indexed under Telangiectasia, Hereditary Hemorrhagic.
Browse Telangiectasia, Hereditary Hemorrhagic studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Drug: Propranolol treatment
Drug: Placebo
40 mg twice a day (morning and evening), per os, during three months
per os, twice a day (morning and evening) during three months
Cumulative duration of epistaxis (in minutes)
Time frame: 6 months after baseline (Day 0)
Frequency of epistaxis (number of episodes) per month
Time frame: At baseline (Day 0), 3 months and 6 months after baseline
Number of cutaneous telangiectasia on hands and face
Time frame: At baseline (Day 0), 3 months and 6 months after baseline.
Levels of hemoglobin
Time frame: At baseline (Day 0), 3 months and 6 months after baseline.
Levels of ferritin
Time frame: At baseline (Day 0), 3 months and 6 months after baseline.
Number of red blood cells transfusions
Time frame: At baseline (Day 0), 3 months and 6 months after baseline.
Short Form (SF) 36 Health Survey
Time frame: At baseline (Day 0), 3 months and 6 months after baseline.
Number of adverse events
Time frame: 3 months and 6 months after baseline (Day 0).
Measurement of blood pressure
Time frame: At baseline (Day 0), 1 month, 3 months and 6 months after baseline.
Measurement of heart rate
Time frame: At baseline (Day 0), 1 month, 3 months and 6 months after baseline.
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Telangiectasia, Hereditary Hemorrhagic →
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