NCT06788314

A Study of Enalapril in Treatment of Venous Malformations

A Single Center, Single Arm, Phase 2, Pilot Study to Investigate the Efficacy of the ACE Inhibitor Enalapril in Participants Aged 18-70 Years of Age With Painful Venous Malformations.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to explore if enalapril can be used to treat painful venous malformations. The main question it aims to answer are: \- Can enalapril reduce pain and volume of the malformation and increase quality of life in patients with painful venous malformations? Participants will: Receive a dose of enalapril 5 mg once daily. If it doesn't have effect the dose of enalapril will be increased to 10 mg daily after 3 months. The treatment duration will be 12 months, with an additional follow-up of 12 months. The visit frequency will be after 1, 3, 6,9 and 12 months and then a follow up visit at 18 and 24 months. Approximately 15 participants will be screened to achieve minimum 10 enrolled participants.

Detailed description

Venous malformations are congenital defects of vasculature and may be disabling for patients throughout life, mostly because of disfigurement and pain. The patients remain challenging to treat as standard of care like sclerotherapy and compression garment is often inadequate in relieving the symptoms. A chance observation has given reason to believe that enalapril may have the potential to reduce pain and volume in venous malformations. A young man with a symptomatic intramuscular venous malformation of the upper limp, and hypertension was treated with an angiotensin-converting enzyme (ACE) inhibitor (enalapril). After 8 months of treatment, it was registered a considerable volume reduction of the malformation and a reduction in pain. Studies have reported that embryonic stem cell-like subpopulations in venous malformations express components of the renin-anigotensin system (RAS). It has been hypothesized that such primitive cells could be a novel therapeutic target by manipulation of the RAS using ACE-inhibitors. The aim of the study is to explore if the chance observation of reduced pain and volume of a venous malformation after enalapril treatment is a coincidence, or if enalapril may play a future role in the treatment of venous malformations.

Conditions

• Venous Malformation
• Pain
• Quality of Life
• Vascular Malformation

Interventions

Type	Name	Description
DRUG	Enalapril	Each participant will receive a dose of enalapril 5 mg once daily. If the participant doesn't have effect of the intervention after 3 months, the dose of enalapril will be increased to 10 mg daily, if the tolerance of enalapril is good. Lack of effect will be defined as unchanged or increased NRS score. Treatment duration will be 12 months.

Timeline

• Start date: 2025-02-01
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2025-01-23
• Last updated: 2025-04-02

Locations

1 site across 1 country: Norway