A Study of Enalapril in Treatment of Venous Malformations
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Patients with venous malformations verified by clinical examination, ultrasound and anatomic MRI with contrast. The venous malformation should have well defined borders and the volume should be measurable on MRI. Diagnosis of venous malformation shall be object for consensus in a multidisciplinary team meeting.
Patients must experience pain from the malformation. Pain is defined as local pain in the malformation, and the participant must have pain that according to the patient inhibits daily activity or pain during nighttime that interferes with sleep. The symptoms has to reduces quality of life. NRS inclusion criteria is greater or equal to 4.
Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
Negative urine pregnancy test in females with childbearing potential. A woman is considered of childbearing potential i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
Disqualifiers
Diffuse VM with no defined borders.
Known diabetes because of the risk of hypoglycemia.
Impaired liver function (INR > 1,5 or aminotransferases > 3 times upper limit of normal
Use of mTOR-inhibitor, racekadotril, sacubitril/valsartan, ramipril or vildagliptin is contraindicated because of an elevated risk of angioedema
Trial design
Treatments tested in this trial
- Enalapril
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov