Status:
COMPLETED
Propranolol for Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
AMRO-HHT-France - Association Maladie de Rendu-Osler
Conditions:
Hereditary Hemorrhagic Telangiectasia
Osler Weber Rendu Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Hereditary Hemorrhagic Telangiectasia (HHT) is a genetic disorder of angiogenesis associated with disabling epistaxis. Management of these nose bleedings requires more effective treatment. Propranolol...
Detailed Description
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 recurr...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Confirmed diagnosis of HHT : 3 or more Curaçao criteria (spontaneous and recurrent epistaxis; multiple telangiectasia at characteristic sites; visceral lesions such as gastrointestinal telangiectasia or arteriovenous malformations; family history: a first degree relative with HHT according to these criteria ) or mutations of genes encoding for ALK1, ENG or SMAD4
- Patient suffering from recurrent epistaxis (more than a mean of 10 episodes/month) and/or with a cumulative mean duration per month more than 20 minutes, according to specific grids completed at least three months before inclusion.
- Patient insured under the French social security system
- Free and informed consent signed by investigator and patient
Exclusion
- Pregnancy or breast-feeding
- Incomplete epistaxis grids in the month prior inclusion
- Current beta-blocker treatment
- Hypersensitivity to the active substance or excipient
- Patients with type I or type II diabetes, treated with insulin, sulphonylureas or meglitinides
- Patients with heart failure
- Patients with liver failure
- Patients with hepatic arteriovenous malformations responsible for high-output cardiac failure or severe hepatic dysfunction
- Patients with severe psoriasis (PASI\>10)
- Contra-indication to beta-blocker treatment : asthma, chronic obstructive bronchopneumopathy, atrioventricular block of second or third degrees without pacemaker, Prinzmetal's angina, bradycardia \< 50bpm, Raynaud's phenomenon, oblitering arteriopathy of the lower limbs, low blood pressure, non-treated pheochromocytoma
- Participation in another clinical therapeutic trial less than 3 months before inclusion
- Protected adult according to french law
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04113187
Start Date
June 23 2020
End Date
May 19 2022
Last Update
June 14 2022
Active Locations (1)
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1
CHU de Bordeaux - service de médecine interne
Bordeaux, France