Study on Enalapril for Adults with Painful Venous Malformations

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Enalapril on a condition known as venous malformations. Venous malformations are abnormal clusters of veins that can cause pain and discomfort. The study aims to explore how Enalapril, which is a type of medication known as an ACE-inhibitor, can help reduce the pain associated with these malformations.

Participants in the study will take Enalapril in the form of a tablet. The study will last for about 12 months, during which the participants’ pain levels and quality of life will be monitored. The study will also use MRI scans to observe any changes in the size of the venous malformations. Throughout the study, any side effects or adverse events will be recorded to ensure the safety of the participants.

The purpose of this study is to understand if Enalapril can effectively reduce pain and improve the quality of life for individuals with venous malformations. By the end of the study, researchers hope to gather valuable information that could lead to better treatment options for those affected by this condition.

1 enrollment

Upon joining the study, eligibility is confirmed through clinical examination, ultrasound, and MRI with contrast to verify the presence of a venous malformation.

Participants must be between 18 and 70 years old and experience pain from the malformation that affects daily activities, sleep, and quality of life.

Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for two weeks after treatment.

2 treatment initiation

The treatment involves taking Enalapril Viatris 5 mg tablets orally. The dosage and frequency will be determined by the study protocol.

The primary goal is to assess changes in pain levels associated with the venous malformation.

3 treatment duration

The treatment with enalapril continues for a period of 12 months.

Participants will be monitored for any changes in pain levels, volume of the malformation as seen on MRI, and overall quality of life.

4 monitoring and assessment

Throughout the study, any adverse events or side effects will be recorded.

The primary endpoint is the change in pain score 12 months after starting treatment compared to the baseline.

Secondary endpoints include changes in the volume of the malformation and quality of life after 12 months.

5 study completion

The study is expected to conclude by May 31, 2029.

Final assessments will be conducted to evaluate the overall impact of the treatment on pain, malformation volume, and quality of life.

Who Can Join the Study?

Patients must have venous malformations confirmed by a doctor through a physical check-up, ultrasound, and a special type of scan called an MRI with contrast. The malformation should have clear edges and its size should be measurable on the MRI. A group of different specialists must agree on the diagnosis.
Patients must feel pain from the malformation. This pain should be in the area of the malformation and must be severe enough to affect daily activities, disturb sleep, and lower the quality of life. The pain level should be 4 or higher on a scale called NRS.
Participants must be between 18 and 70 years old when they agree to join the study.
Women who can have children must have a negative urine pregnancy test before joining. A woman is considered able to have children from her first period until menopause unless she has had a permanent procedure to prevent pregnancy, like removal of the uterus or ovaries.
Women who can have children must use very effective birth control methods while taking the study medicine and for up to 2 weeks after treatment. These methods include certain hormonal contraceptives, devices placed in the uterus, surgical procedures, having a partner who has had a vasectomy, or not having sex at all.
Participants must be able to understand and sign a consent form, which means they agree to follow the study rules. They must also be able to answer questions about their quality of life. Since the questions are in Norwegian and English, they should understand one of these languages.

Who Cannot Join the Study?

Individuals who are not experiencing pain related to a venous malformation cannot participate. A venous malformation is a type of blood vessel abnormality.
Participants must be within the specified age range, which is not detailed here.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals who are considered part of a vulnerable population are not excluded, meaning they can participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

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Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Enalapril Maleate

ACE-Inhibitor is a medication used in this trial to help reduce pain associated with venous malformations. It works by relaxing blood vessels, which can improve blood flow and reduce the pressure in the veins, potentially alleviating pain. This study aims to see how effective this medication is in managing pain for participants with this condition.

Investigated diseases:

Arteriovenous malformation

Venous Malformation – Venous malformation is a type of vascular anomaly where veins are abnormally formed, leading to a network of enlarged and tangled veins. These malformations are present at birth and grow proportionally with the individual. They can occur anywhere in the body but are most commonly found in the skin, muscles, and bones. As they grow, they may cause pain, swelling, and a feeling of heaviness in the affected area. Over time, venous malformations can lead to complications such as bleeding or clotting within the malformed veins. The condition is typically non-cancerous and progresses slowly throughout a person’s life.

Trial ID:

2023-510076-31-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Enalapril for Adults with Painful Venous Malformations

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