Propranolol for Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: AMRO-HHT-France - Association Maladie de Rendu-Osler
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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