A Study of Enalapril in Treatment of Venous Malformations

Launched by OSLO UNIVERSITY HOSPITAL · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called enalapril to see if it can help treat painful venous malformations, which are abnormal clusters of veins that can cause discomfort and affect daily life. The main goals are to find out if enalapril can reduce the pain and size of these malformations and improve the overall quality of life for those affected. Participants in the trial will take enalapril once a day for 12 months, with regular check-ups every few months to monitor their progress. If the initial dose does not seem effective after three months, it may be increased.

To join the trial, participants need to be between 18 and 70 years old and have been diagnosed with a venous malformation that causes significant pain. They should also be able to communicate in English or Norwegian, as they will need to answer questions about their quality of life. Women of childbearing age must take precautions to avoid pregnancy while participating in the study. This trial is currently recruiting around 10 participants, and it offers a chance to contribute to research that may lead to better treatments for others facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
• • 4. 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.
• 5. 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 (controlled with regular questioning by PI)
• • 6. 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 adequately questionnaires regarding quality of life. Since the questionnaire are validated in Norwegian and English they also should control one of this language.
• Exclusion Criteria:
• • 1. Diffuse VM with no defined borders.
• • 2. Known diabetes because of the risk of hypoglycemia.
• • 3. Impaired liver function (INR \> 1,5 or aminotransferases \> 3 times upper limit of normal
• • 4. Use of mTOR-inhibitor, racekadotril, sacubitril/valsartan, ramipril or vildagliptin is contraindicated because of an elevated risk of angioedema
• • 5. Use of angiotensin-II receptor antagonist or alsikiren (direct renin inhibitor) is contraindicated because of increased risk of hypotension, hyperkalemia, and impaired renal function.
• • 6. Impaired cardiac function and clinically significant cardiac disease including aorta- and mitral valve stenosis and hypertrophic cardiomyopathy.
• • 7. Lactose intolerance, total lactase deficiency or glucose-galactose malabsorption because Enalapril contains lactose.
• • 8. 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 syndrome, or small bowel resection.)
• • 9. 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.
• • 10. Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicated participation in the clinical study.
• • 11. Known renal artery stenosis.
• • 12. Patients with a history of angioneurotic edema related to previous treatment with ACE-inhibitors and patients with Hereditary or ideopatic anigioneurotic edema.
• • 13. Contraindications for MRI (cardiac pacemaker or defibrillator, intracranial clips, cochlear implants or other metallic foreign bodies, claustrophobia.
• • 14. BMI\> 30
• • 15. Impaired kidney function (eGFR\< 50)
• • 16. Pregnant or lactating woman
• • 17. Any condition that in the view of the investigator would suggest that the patient is unable to compley with the study protocol and procedures.