All studies
AuthorisedTherapeutic exploratory (Phase II)Interventional

Swedish Cardiac And Renal Failure study-1 (SCARF-1): An open-label pilot trial to evaluate the feasibility, safety and efficacy of eplerenone in patients with heart failure with reduced ejection fraction and severe chronic kidney disease.

This pilot study, called SCARF-1, is looking into a medicine called eplerenone for people who have both heart failure (where the heart doesn't pump blood as well as it should) and severe kidney disease. The main aim is to see if this medicine is a practical and safe option, and to understand how well it works. Researchers are particularly interested in whether participants can complete the treatment without needing other medications to control their potassium levels, which can sometimes be affected by eplerenone. They will also be closely monitoring kidney function, heart failure symptoms, and overall well-being throughout the study to make sure it's safe and effective for this group of patients.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Karolinska Institutet
Enrolment target
40
Start
12 Aug 2025

What is this study about?

This research study, called SCARF-1, is looking at a medicine called eplerenone. It's for people who have two serious health issues at the same time: heart failure with reduced 'ejection fraction' (meaning the heart struggles to pump enough blood around the body) and severe long-term kidney disease. The purpose of this study is to explore if eplerenone is a practical and safe treatment for these patients, and to get an idea of how well it works for them.

Eplerenone is a medicine that helps the heart, but it can sometimes affect potassium levels in the body, which is particularly important for people with kidney disease. The main thing the researchers want to find out is whether people can complete the entire treatment period with eplerenone, and if they do, whether they also need to take other medicines to help keep their potassium levels balanced. This will help them understand if it's a suitable treatment option for this specific group of patients.

The study will also look at many other important things. For example, they'll check how well people can exercise, how their symptoms of heart failure change, and their overall quality of life. They will also carefully watch for any side effects, including changes in potassium levels or kidney function, and whether participants need to go to hospital for any reason. This detailed information will help doctors understand more about using eplerenone safely and effectively for people with both heart and severe kidney problems.

Key takeaways

  • This study is for people with specific types of heart failure and severe kidney disease.
  • It's checking a medicine called eplerenone for safety and how well it works.
  • Researchers are particularly interested in managing potassium levels.
  • Participation involves taking eplerenone and having regular check-ups.
  • Your symptoms, exercise ability, and overall well-being will be monitored.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for people aged 18 or older. Both men and women can take part.

To be considered for this study, you must have been diagnosed with both heart failure where your heart isn't pumping blood as effectively as it should (this is specific type of heart failure) AND severe chronic kidney disease (meaning your kidneys aren't working as well as they should be for a long time).

There might be other health conditions or medications that would prevent you from joining, as the researchers need to make sure the study is right for you and safe. Your doctor or the study team would discuss all these details with you.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with heart failure where your heart's pumping is reduced?
  3. Do you also have severe chronic kidney disease?
  4. Are you able to attend regular clinic visits for check-ups and tests?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the medicine eplerenone. This is an 'open-label' study, which means both you and your doctor will know you are taking this specific medicine. The researchers will closely monitor your health throughout the treatment period. This will involve regular visits to the clinic, where you might have blood tests to check your potassium levels and kidney function, as well as tests to measure your heart failure symptoms, how far you can walk, and how you're feeling overall. The study team will explain how often these visits are needed and for how long the entire study will last.

Potential risks and benefits

Taking part in this study might offer a potential benefit by giving you access to a medication that could help manage your heart failure and severe kidney disease. However, like all medicines, eplerenone can have side effects, and some risks are being closely monitored, such as changes in potassium levels, kidney function, and feeling dizzy. The research team will explain all known side effects. You are always in control and can decide to stop participating in 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.
  • Unverified
    Sweden

Common questions

What is 'eplerenone'?

Eplerenone is a medicine used to treat heart failure. It works by blocking certain hormones that can harm the heart and blood vessels.

What does 'heart failure with reduced ejection fraction' mean?

It means your heart's main pumping chamber doesn't push out as much blood as it should with each beat. This can make you feel tired or short of breath.

What is 'severe chronic kidney disease'?

This means your kidneys are not working properly to filter waste from your blood, and it's a long-lasting condition.

What is a 'potassium binder'?

A potassium binder is a medicine that helps your body remove extra potassium, usually taken if your potassium levels get too high.

Will I know if I'm getting the actual medicine?

Yes, this is an 'open-label' study, so you and your doctor will know you are receiving eplerenone.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.