Expression of the Components of the Renin-Angiotensin System in Venous Malformation.
Sam Siljee, Emily Keane, Reginald Marsh...
https://pubmed.ncbi.nlm.nih.gov/27200356Actively Recruiting
Phase 2
Age: 18Years - 70Years
All Genders
ID06788314
A Single Center, Single Arm, Phase 2 Pilot Study to Investigate the Effect of Enalapril in Adults Aged 18-70 Years With Painful Venous Malformations
Led by Oslo University Hospital · Updated on 2025-04-02
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the potential use of enalapril to treat painful venous malformations, which are congenital vascular defects that can cause disfigurement and pain, affecting patients' quality of life. The study investigates whether enalapril can reduce the pain and volume of these malformations and improve quality of life in affected patients aged 18 to 70. The trial is a phase 2, single-center, single-arm pilot study led by Oslo University Hospital.
CONDITIONS
Brief Title
A Study of Enalapril in Treatment of Venous Malformations
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with venous malformations confirmed by clinical exam, ultrasound, and MRI with measurable volume and clear borders
- Pain from the malformation that interferes with daily activities or sleep and reduces quality of life, with a pain score of 4 or higher
- Adults aged 18 to 70 years at the time of consent
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential must use effective contraception during the study and for 2 weeks after treatment
- Ability to provide informed consent and complete quality of life questionnaires in Norwegian or English
You will not qualify if you...
- Diffuse venous malformations without defined borders
- Known diabetes
- Impaired liver function (INR > 1.5 or liver enzymes > 3 times normal)
- Use of certain medications including mTOR inhibitors, racekadotril, sacubitril/valsartan, ramipril, vildagliptin, angiotensin-II receptor antagonists, or direct renin inhibitors
- Impaired cardiac function or significant heart disease
- Lactose intolerance or related digestive disorders
- Gastrointestinal conditions affecting absorption of ACE inhibitors
- Allergy to enalapril or other ACE inhibitors
- Severe or uncontrolled medical conditions contraindicating study participation
- Known renal artery stenosis
- History of angioneurotic edema or hereditary angioedema
- Contraindications to MRI (e.g., pacemakers, metal implants, claustrophobia)
- Body mass index over 30
- Impaired kidney function (eGFR < 50)
- Pregnant or breastfeeding women
- Any condition preventing compliance with study procedures
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive daily doses of enalapril to explore its effect on pain and volume of venous malformations. The dose may be increased after 3 months if there is no improvement and tolerance is good.
Regular visits during treatment period as scheduled by the study team
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
N
Nina Haagenrud Schultz, MD, PhD
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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Published Research Related To This Trial
Embryonic Stem Cell-Like Subpopulations in Venous Malformation.
Elysia M S Tan, Sam Duro Siljee, Helen D Brasch...
https://pubmed.ncbi.nlm.nih.gov/29046873Embryonic Stem Cell-like Population within Venous Malformation Expresses the Renin-Angiotensin System.
Elysia M S Tan, Helen D Brasch, Paul F Davis...
https://pubmed.ncbi.nlm.nih.gov/31321175Regression of a venous malformation during angiotensin-converting enzyme inhibitor treatment for hypertension.
Sigurd Berger, Therese Halvorsen Bjark, Karsten Midtvedt...
https://pubmed.ncbi.nlm.nih.gov/36262918