Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Peripheral Edema Resolution evaluated in patients switched from amlodipine to Levamlodipine (PERLA)

This study, called PERLA, is for people who experience swelling in their ankles or feet (oedema) while taking amlodipine for a long time. Amlodipine is a medication often prescribed for high blood pressure or angina. The main goal of this research is to see if switching from amlodipine to a related medicine called S-amlodipine (VAM) can help reduce this swelling. Researchers will carefully measure changes in foot and ankle swelling using different methods, including special water displacement tests and measurements. They will also ask patients about their experiences. The study aims to find a way to make treatment more comfortable for people who get swollen ankles or feet from their current medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Zentiva k.s.

Enrolment target

Start

10 Jun 2024

Patients with moderate or severe oedema on a long-term treatment with amlodipine

What is this study about?

You might be familiar with amlodipine if you're taking it for high blood pressure or angina. It's a very effective medicine, but for some people, a common side effect is swelling in the ankles or feet, known as oedema. This can be uncomfortable and affect daily life. This study, named PERLA, is exploring a potential solution to this problem.

The researchers want to see if a slightly different version of the same medicine, called S-amlodipine (VAM), could help. Think of it like this: amlodipine has two parts, like two hands. The S-amlodipine part is thought to be the one that does most of the good work for your heart, while the other part might contribute more to the side effects like swelling. By switching to S-amlodipine, the study hopes to reduce the swelling while still keeping your blood pressure or angina under control.

This research is particularly important because it aims to improve the quality of life for people who rely on amlodipine but are bothered by the swelling. If S-amlodipine proves to be effective at reducing oedema, it could offer a better treatment option for many, making their long-term medication use more comfortable and manageable.

Key takeaways

This study investigates if a different version of amlodipine (S-amlodipine) can reduce ankle/foot swelling.
It's for people who get oedema from long-term amlodipine use.
Researchers will meticulously measure swelling and gather patient feedback.
The goal is to find a more comfortable treatment for amlodipine-related oedema.
Participation involves switching medications, regular checks, and diary keeping.

Who may be eligible?

This study is looking for adults who are currently taking amlodipine and have been experiencing moderate to severe swelling in their ankles or feet as a side effect. You need to be 18 years old or older to be considered for the study.

It's important that your doctor has confirmed that the swelling you're experiencing is indeed a side effect of amlodipine. Both men and women are welcome to take part if they meet the other criteria.

The researchers will also make sure that there aren't any other health conditions that might affect the study results or your safety while participating. If you think this sounds like you, it's always best to chat with your doctor or the study team to see if you're a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you currently take amlodipine for high blood pressure or angina?
Do you experience moderate to severe swelling in your ankles or feet?
Has your doctor said this swelling is likely due to amlodipine?
Are you able to attend regular study visits?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a screening visit where doctors will check if you're suitable. Over several periods, doctors will carefully monitor your ankle and foot swelling. They will use a special method that measures how much water your foot displaces, as well as measuring your ankle size. You'll also be asked to fill out questionnaires about your swelling and how you feel.

Throughout the study, you'll switch from your current amlodipine to the new S-amlodipine (VAM) at certain times, or continue with a specific dose of amlodipine. You'll need to keep a diary of the medicine you take. You'll have regular visits where your vital signs (like blood pressure and heart rate) will be checked, and doctors will assess your overall health and any side effects. The total duration of the study will involve several visits over a period of time, with careful follow-up after each treatment phase.

Potential risks and benefits

Taking part in this study could potentially help reduce the swelling in your ankles or feet, making you more comfortable. Your health will be closely monitored by medical professionals throughout the study. However, like all medicines, S-amlodipine might have side effects, which the study team will explain to you before you agree to participate. There's also the chance that switching medicines might not improve your swelling or could even slightly worsen it. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is oedema?

Oedema is the medical term for swelling, often caused by fluid build-up in parts of the body, commonly the ankles, feet, or legs.

Why would amlodipine cause swelling?

Amlodipine can sometimes cause blood vessels to widen more in some areas of the body, leading to fluid leaking into the surrounding tissues, which results in swelling.

What is S-amlodipine (VAM)?

S-amlodipine is a specific component of the amlodipine medicine that is thought to be more active in treating blood pressure while potentially causing less swelling.

Will I know if I'm getting S-amlodipine or regular amlodipine?

In some parts of the study, you might switch between the different medicines. The study will ensure you know what medicine you are taking at each stage, and doctors will monitor you closely.

What's the 'water displacement method'?

This is a way to accurately measure swelling by seeing how much water is pushed out when you place your foot or ankle into a container of water.