Status:
RECRUITING
Propranolol and Von Hippel-Lindau Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Agence Générale des Equipements et Produits de Santé
Conditions:
Hemangioblastoma of CNS
Von Hippel-Lindau Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Propranolol (beta-blocker), is successfully used for the treatment of infantile hemangiomas, the most common vascular tumor of newborns. The mechanism is related to its anti-angiogenetic and pro-apopt...
Detailed Description
'Von Hippel-Lindau disease (VHL) is a familial syndrome, autosomal dominant, of predisposition to cancer, associating malignant tumors (renal carcinomas, neuroendocrine tumors of the pancreas), or ben...
Eligibility Criteria
Inclusion
- Age ≥ 18
- VHL patient with one or more hemangioblastomas of the central nervous system, none of which require urgent surgery (within 3 months)
- Patient with written consent to participate in the study
- Enrolled in a social security plan or beneficiary
Exclusion
- Contraindication to the use of propranolol:
- chronic obstructive pulmonary disease and asthma,
- uncontrolled heart failure,
- 2nd and 3rd degree atrioventricular blocks,
- bradycardia (\<50 beats/minute after 3 minutes of rest),
- Raynaud's phenomenon and peripheral arterial disorders,
- arterial hypotension,
- hypersensitivity to propranolol
- cardiogenic shock,
- Prinzmetal's angina,
- sinus disease (including sino-auricular block)
- untreated pheochromocytoma,
- history of anaphylactic reaction,
- in the context of primary and secondary prevention of digestive bleeding in cirrhotics: advanced liver failure with hyperbilirubinemia, massive ascites, hepatic encephalopathy
- predisposition to hypoglycemia (as after fasting or in case of abnormal response to hypoglycemia)
- metabolic acidosis
- Contraindication to MRI:
- claustrophobia,
- presence of a pace maker and other stimulators/implants
- ocular metallic foreign bodies,
- heart valves or ferromagnetic metal vascular clips
- Patients already on Propranolol or other beta blockers
- Patients under guardianship or conservatorship
- Pregnant or breastfeeding women - Woman with a medium-term pregnancy project
Key Trial Info
Start Date :
January 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT05424016
Start Date
January 16 2023
End Date
November 1 2026
Last Update
December 13 2023
Active Locations (1)
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1
AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94275