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New treatment option for Venous Malformation
Official title A Study of Enalapril in Treatment of Venous Malformations
ClinicalTrials.gov ID: NCT06788314
What this study is testing
What is Enalapril?
Enalapril is an investigational medicine, given as an once-daily injection into a muscle, being studied as a potential treatment for venous malformation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients with venous malformations verified by clinical examination, ultrasound and anatomic MRI with contrast. The venous malformation should have...
- Patients must experience pain from the malformation. Pain is defined as local pain in the malformation, and the participant must have pain that...
- 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...
- Woman of childbearing potential (WOCBP) must use highly effective contraception measures while on study medicine and for up to 2 weeks past treatment:
You likely can't join if
- 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
- Use of angiotensin-II receptor antagonist or alsikiren (direct renin inhibitor) is contraindicated because of increased risk of hypotension...
- Impaired cardiac function and clinically significant cardiac disease including aorta- and mitral valve stenosis and hypertrophic cardiomyopathy.
See the full eligibility criteria
- 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...
- 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...
- 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...
- Woman of childbearing potential (WOCBP) must use highly effective contraception measures while on study medicine and for up to 2 weeks past treatment:
- Combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation.
- Progestogen-only hormonal contraception associated with inhibition of ovulation Intrauterine device (IUS) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomized partner Sexual abstinence...
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). They must also be capable of answer...
- 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
- Use of angiotensin-II receptor antagonist or alsikiren (direct renin inhibitor) is contraindicated because of increased risk of hypotension, hyperkalemia, and impaired renal function.
- Impaired cardiac function and clinically significant cardiac disease including aorta- and mitral valve stenosis and hypertrophic cardiomyopathy.
- Lactose intolerance, total lactase deficiency or glucose-galactose malabsorption because Enalapril contains lactose.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the ACE-inhibitor (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea \> grade 2, malabsorption...
- Hypersensitivity to the active substance or any of the excipients listed in section 6.1 of the SmPC of enalpril or to other ACE-inhibitors.
- Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicated participation in the clinical study.
- Known renal artery stenosis.
- Patients with a history of angioneurotic edema related to previous treatment with ACE-inhibitors and patients with Hereditary or ideopatic anigioneurotic edema.
- Contraindications for MRI (cardiac pacemaker or defibrillator, intracranial clips, cochlear implants or other metallic foreign bodies, claustrophobia.
- BMI\> 30
- Impaired kidney function (eGFR\< 50)
- Pregnant or lactating woman
- Any condition that in the view of the investigator would suggest that the patient is unable to compley with the study protocol and procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.