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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Enalapril
DrugEach 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: EnalaprilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To explore the change of venous malformation related pain
Changes in NRS (Numeric rating scale). NRS is an analogue scale with numbers from 0-10, where 0 represents no pain and 10 represents the worst imaginable pain.
Time frame
From baseline and to the end of treatment at 12 months.Secondary outcomes
1
To explore volume change of the venous malformation
Volume will be assessed by MRI. To estimate the volume of the venous malformation the area of the malformation on multiple adjacent MRI slices will be added and multiplied by the slice thickness. The volume change at follow-up imaging is calculated according to this formula: (Volume at baseline - volume at follow up)/ (volume at baseline) x 100 = percentage volume change.
Time frame
From baseline to the end of treatment at 12 months.2
To explore change in quality of life in patients with venous malformations
Quality of life, will be assessed by the SF-36 (Short Form) questionnaire. The SF-36 consists of 36 questions measuring quality of life in 4 mental domains and 4 physical domains, supplying general information about life quality. The score of the SF-36 ranging from 0-100. Higher score ranging better health status.
Time frame
From baseline to the end of treatment at 12 months.3
To explore change in quality of life in patients with venous malformations
Quality of life, will be assessed by the OVAMA score (Outcome measures for vascular malformations). The OVAMA score is a disease specific patient-reported-outcome-measures consisting of 23 questions measuring quality of live with a general symptom scale with 6 items, a head and neck symptom scale with 8 items, and an appearance scale with 9 items.
Time frame
From baseline to the end of treatment at 12 months.Sponsors and contacts
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Source ClinicalTrials.gov