Propranolol for Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 27 June 2022
• Main ID: NCT04113187
• Date of registration: 27/09/2019
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Bordeaux
• Public title: Propranolol for Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients EPERO
• Scientific title: Study of the Efficacy of Propranolol for the Management of Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients
• Date of first enrolment: June 23, 2020
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04113187
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Anne CONTIS, MD
• Affiliation: University Hospital, Bordeaux

• Name: Antoine BENARD, MD, PhD
• Affiliation: University Hospital, Bordeaux

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hereditary Hemorrhagic Telangiectasia

Osler Weber Rendu Disease

Intervention(s)

Drug: Placebo

Drug: Propranolol treatment

Primary Outcome(s)

Cumulative duration of epistaxis (in minutes) [Time Frame: 6 months after baseline (Day 0)]

Secondary Outcome(s)

Number of adverse events [Time Frame: 3 months and 6 months after baseline (Day 0).]

Levels of ferritin [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.]

Short Form (SF) 36 Health Survey [Time Frame: At baseline (Day 0), 3 months and 6 months after baseline.]

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.]

Number of red blood cells transfusions [Time Frame: At baseline (Day 0), 3 months and 6 months after baseline.]

Frequency of epistaxis (number of episodes) per month [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.]

Secondary ID(s)

CHUBX 2015/32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AMRO-HHT-France - Association Maladie de Rendu-Osler