Enalapril maleate for Venous malformation

Inclusion criteria

• {"criterion_text":"- 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.\n- 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\n- Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.\n- 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.\n- Woman of childbearing potential (WOCBP) must use highly effective contraception measures while on study medicine and for up to 2 weeks past treatment. Highly effective birth control methods include: ■\tCombined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation. ■\tProgestogen-only hormonal contraception associated with inhibition of ovulation ■\tIntrauterine device (IUS) ■\tIntrauterine hormone-releasing system (IUS) ■\tBilateral tubal occlusion ■\tVasectomized partner ■\tSexual abstinence (controlled with regular questioning by PI)\n- 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

• {"criterion_text":"- Diffuse VM with no defined borders.\n- Use of mTOR-inhibitor, racekadotril, sacubitril/valsartan, ramipril or vildagliptin is contraindicated because of an elevated risk of angioedema\n- Use of angiotensin-II receptor antagonist or alsikiren (direct renin inhibitor) is contraindicated because of increased risk of hypotension, hyperkalemia, and impaired renal function.\n- Impaired cardiac function and clinically significant cardiac disease including aorta- and mitral valve stenosis and hypertrophic cardiomyopathy.\n- Lactose intolerance, total lactase deficiency or glucose-galactose malabsorption because Enalapril contains lactose.\n- 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.)\n- Hypersensitivity to the active substance or any of the excipients listed in section 6.1 of the SmPC of the SmPC of enalpril or to other ACE-inhibitors.\n- Patients with a history of angioneurotic edema related to previous treatment with ACE-inhibitors and patients with Hereditary or ideopatic anigioneurotic edema\n- Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, contraindicated participation in the clinical study\n- Known renal artery stenosis\n- BMI > 30\n- Impaired renal function (eGFR < 50 ml/min/1,73m2)\n- Pregnant or lactating woman\n- Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures.\n- Known diabetes because of the risk of hypoglycemia.\n- Impaired liver function (INR > 1,5 or aminotransferases > 3 times upper limit of normal)\n- Contraindications for MRI (cardiac pacemaker or defibrillator, intracranial clips, cochlear implants or other metallic foreign bodies, claustrophobia.)"}

Primary endpoints

• {"endpoint_text":"- Change in NRS score 12 months after treatment start with enalapril compared to baseline.","definition_or_measurement_approach":"Change in NRS score at 12 months compared to baseline (NRS measured at baseline and at 12 months)."}

Secondary endpoints

• {"endpoint_text":"- Volume change on MRI 12 months after treatment start with enalapril compared to baseline.","definition_or_measurement_approach":"Volume measured by MRI at baseline and at 12 months; change compared to baseline."}
• {"endpoint_text":"- Change in Quality of life 12 months after treatment start with enalapril compared to baseline.","definition_or_measurement_approach":"Quality of life assessed at baseline and at 12 months; change compared to baseline."}
• {"endpoint_text":"- Register adverse events > or equal to grade 2 and side effects continues during the study","definition_or_measurement_approach":"Adverse events of grade ≥2 recorded during the study period; ongoing side effects tracked throughout the study."}

Norway

Latest Decision Or Authorization Date

17-12-2024

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway