Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease

This study focuses on improving blood vessel health, specifically addressing 'vascular stiffness,' in individuals living with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Researchers are comparing the effects of a high-salt diet to a normal diet, with some participants receiving a 'dummy' treatment (placebo) made from potato starch. They will also be testing a medication called amiloride, which is already used for other conditions, to see if it can help reduce blood vessel stiffness. This is a Phase IV study, meaning it's looking at treatments already approved but investigating new uses or comparisons. The main goal is to understand how diet and amiloride impact the stiffness of blood vessels, which is an important aspect of overall heart and kidney health in ADPKD.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

24 May 2024

Autosomal Dominant Polycystic Kidney Disease

What is this study about?

This research study is looking into how we can improve the health of blood vessels in people who have Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD is a genetic condition where cysts grow in the kidneys, which can sometimes lead to other health issues. One area of concern is 'vascular stiffness,' which means the blood vessels become less flexible. This can be important for heart and kidney health.

The study aims to understand if certain changes in diet, specifically a high-salt diet, and a medication called amiloride can affect how stiff blood vessels are. To do this, some participants will try a high-salt diet, while others will have a normal diet and take a 'placebo,' which is a harmless inactive substance like potato starch. They will also look at how amiloride, a medication sometimes used to help with fluid balance, impacts blood vessel stiffness in both groups. This is a re-evaluation of treatments that are already available.

Researchers will be measuring how stiff blood vessels are using a method called 'pulse wave velocity' (PWV). They will be comparing measurements before and after the different diets and treatments. They will also check other things like blood pressure, signs of inflammation in the blood, and even how salt is stored in the body using special scans. The overall goal is to find new ways to help people with ADPKD maintain healthier blood vessels.

Key takeaways

This study is about improving blood vessel health in ADPKD.
It compares a high-salt diet to a placebo (potato starch).
It tests an existing medication, amiloride, for its effect on blood vessel stiffness.
Measurements include blood vessel stiffness, blood pressure, and blood tests.
Aims to find new ways to help people with ADPKD.

Who may be eligible?

This study is open to both men and women. You must be at least 18 years old to take part; there is no upper age limit. This means that if you are an adult with ADPKD, you might be able to join.

The study team will need to check your full medical history to make sure that participating would be safe and appropriate for you. They will confirm if you meet all the specific requirements before you can join the study.

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 have Autosomal Dominant Polycystic Kidney Disease (ADPKD)?
Are you comfortable with the idea of potentially following a specific diet for a period?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits where different tests and measurements will be conducted. You would be assigned to either a high-salt diet or a normal diet group, and you might receive either a potato starch placebo or the medication amiloride. The potato starch acts as a 'dummy' treatment for comparison. You would have your blood vessel stiffness measured using a method called pulse wave velocity (PWV), which is a non-invasive test. Blood pressure will be monitored, and blood samples will be taken to check for markers of inflammation. Some participants might also have special scans (23Na-MRI) to look at salt storage in the body, and your salt taste sensitivity will be tested. The total duration of your participation in the study, including all treatments and follow-up, would be made clear to you by the study team.

Potential risks and benefits

Participating in research studies always carries potential benefits and risks. You might not directly benefit from taking part in this specific study, but the information gained could help others with ADPKD in the future by improving understanding of blood vessel health. Potential risks might include discomfort from blood tests, temporary side effects from the study medication (amiloride), or effects from the high-salt diet if you are in that group. The study team will closely monitor your health throughout. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Netherlands

Common questions

What is 'vascular stiffness'?

Vascular stiffness means your blood vessels are less flexible than they should be, which can affect how well blood flows through your body.

What is a 'placebo'?

A placebo is a 'dummy' treatment, like the potato starch in this study. It looks and feels like the real medication but has no active ingredients.

What is amiloride?

Amiloride is a medication that's already approved for use in certain conditions, helping to balance fluid in the body. This study is exploring if it can also help with blood vessel stiffness.

Will I know if I'm getting the high-salt diet or the placebo?

Often in studies like this, participants don't know which group they are in (e.g., high-salt vs. normal diet with placebo) to keep the results fair and unbiased. The study team will explain how this works.

Why is this study important for people with ADPKD?

Understanding how diet and medications affect blood vessel stiffness could lead to better ways to manage the overall health of people with ADPKD.