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Terminated NCT04113187

Propranolol for Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients

Conditions: Hereditary Hemorrhagic Telangiectasia, Osler Weber Rendu Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 15
Sponsor: University Hospital, Bordeaux

Location: CHU de Bordeaux - service de médecine interne Bordeaux

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.

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04113187). StuddyBuddy aggregates publicly available trial information.