Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure (OPRA-HF)

This research study, called OPRA-HF, is testing a new medicine, Sodium Zirconium Cyclosilicate (SZC), for people with heart failure. Some heart failure medicines, called MRAs, are very helpful but can sometimes cause potassium levels in the blood to go too high. This study wants to find out if SZC can help keep potassium levels normal, allowing people to take the right dose of their MRA heart medicine without problems. If successful, this could mean better treatment for heart failure. We'll compare SZC to a placebo (a dummy medicine) to see how well it works and if it's safe. Participants will be aged 18 or over.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vaestra Goetalandsregionen

Enrolment target

Start

14 Aug 2024

High-risk hyperkalemia Heart failure Suboptimal heart failure treatment

What is this study about?

Imagine you have heart failure, and your doctor prescribes an important medicine called an MRA. These medicines are very good for your heart, but sometimes they can cause a side effect where the potassium in your blood gets too high. High potassium can be risky, so doctors often have to reduce the dose of the MRA or even stop it altogether, which means you might not be getting the best possible treatment for your heart.

This study, called OPRA-HF, is looking at a new medicine called Sodium Zirconium Cyclosilicate (SZC). The idea is that SZC might help to keep your potassium levels normal, even when you're taking your MRA. If it works, this would mean people with heart failure could stay on the most effective dose of their MRA medicine for longer, helping their heart better and improving their overall health.

We'll be comparing SZC with a 'placebo', which looks exactly like the study medicine but doesn't contain any active drug. This helps us to see if any changes are really due to SZC or if they would have happened anyway. We'll be closely monitoring potassium levels and how well participants are able to keep taking their MRA heart medicine.

Key takeaways

This study tests a new medicine (SZC) for people with heart failure.
It aims to help them take important heart medicines (MRAs) more safely.
The goal is to keep potassium levels normal and get the best heart treatment.
Participants will receive either SZC or a placebo.
Regular check-ups and blood tests will monitor safety and effectiveness.
Participation could improve heart failure treatment for others in the future.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. Both men and women can take part.

You would be considered for this study if you have heart failure and are currently taking a specific type of heart medication called an MRA. The study is particularly interested in people who have had problems with high potassium levels in the past while taking these important heart medicines, or who might be at risk of high potassium.

The research team will carry out some checks to make sure the study is a good fit for you and that it's safe for you to take part. They will explain all the details during your first visit.

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 a diagnosis of heart failure?
Are you currently taking a heart medicine called an MRA?
Have you had issues with high potassium levels in your blood, or are your doctors concerned about them whilst on MRA therapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the study medicine (Sodium Zirconium Cyclosilicate) or a placebo. You won't know which one you're getting, and neither will your doctor for most of the study. The medication comes as a powder to be mixed with water and taken by mouth.

You'll have regular hospital visits for check-ups, blood tests (especially to monitor your potassium levels), and to discuss how you're feeling. These visits will help the research team see how the medicine is working and make sure you're safe. The total length of your participation in the study, including all visits and follow-up, will be explained by the study team, but generally, these types of studies can last several months.

Potential risks and benefits

Taking part in this study might offer some potential benefits. If you receive the active study medicine, it could help you continue taking your important heart failure medication (MRA) at an effective dose by keeping your potassium levels stable, potentially improving your heart health. Even if you receive the placebo, your health will be closely monitored by a specialist team throughout the trial. However, there are potential risks, as with any medication, including possible side effects from the study drug, or the inconvenience of extra hospital visits and blood tests. You have the right 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
Sweden

Common questions

What is 'heart failure'?

Heart failure means your heart isn't pumping blood as well as it should. It doesn't mean your heart has stopped, but it might struggle to keep up with your body's needs.

What is 'hyperkalemia'?

Hyperkalemia means you have too much potassium in your blood. Our bodies need potassium, but too much can be harmful, especially for your heart.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real thing but doesn't contain any active drug. It helps researchers understand if the new medicine is truly effective.

Will I know if I'm getting the real medicine or the placebo?

Most of the time, neither you nor your doctors will know whether you are receiving the real study medicine or the placebo. This helps make the study results more reliable.

What are MRAs?

MRAs are a type of medicine often used for heart failure. They can help your heart but sometimes need careful monitoring due to potassium levels.