Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06788314

A Study of Enalapril in Treatment of Venous Malformations

Led by Oslo University Hospital · Updated on 2025-04-02

12

Participants Needed

1

Research Sites

304 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of Enalapril in Treatment of Venous Malformations

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with venous malformations confirmed by clinical exam, ultrasound, and MRI with measurable volume and clear borders
  • Experience pain from the malformation that reduces quality of life, with pain score (NRS) of 4 or higher
  • Aged 18 to 70 years at time of consent
  • Negative urine pregnancy test for women with childbearing potential
  • Women of childbearing potential must use effective contraception during treatment and for 2 weeks after
  • Able to provide informed consent and complete quality of life questionnaires in Norwegian or English
Not Eligible

You will not qualify if you...

  • Diffuse venous malformations without defined borders
  • Known diabetes
  • Impaired liver function (INR > 1.5 or aminotransferases more than 3 times normal)
  • Use of certain medications including mTOR-inhibitors, racekadotril, sacubitril/valsartan, ramipril, or vildagliptin
  • Use of angiotensin-II receptor antagonists or direct renin inhibitors
  • Significant cardiac disease including impaired heart function or specific valve diseases
  • Lactose intolerance or glucose-galactose malabsorption
  • Gastrointestinal diseases affecting drug absorption
  • Allergy to enalapril or other ACE inhibitors
  • Other severe or uncontrolled medical conditions
  • Known renal artery stenosis
  • History of angioneurotic edema or hereditary/idiopathic angioneurotic edema
  • Contraindications for MRI such as pacemakers, cochlear implants, or claustrophobia
  • Body mass index over 30
  • Impaired kidney function (eGFR less than 50)
  • Pregnant or breastfeeding women
  • Any condition that may prevent compliance with the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oslo University Hospital, Rikshospitalet

Oslo, Norway, Norway

Actively Recruiting

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Research Team

C

Christina Bjerring Opheim, MD and PhD student

CONTACT

N

Nina Haagenrud Schultz, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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