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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

DECISION; Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands

The DECISION study is checking how well a long-used medicine called digoxin works for people living with heart failure. Heart failure means your heart isn't pumping blood as effectively as it should. This study is focusing on patients who are managing their heart failure at home, rather than in hospital. Researchers want to understand if digoxin can help reduce the number of times people need to go to the hospital because of their heart failure or visit a hospital urgently for heart problems. They are also looking at whether it can help prevent deaths related to heart issues. The study is also researching other important things like how it affects overall health, quality of life, and any possible side effects.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Universitair Medisch Centrum Groningen
Enrolment target
982
Start
18 Oct 2024

What is this study about?

The DECISION study is an important research project looking into a medicine called digoxin. Digoxin has been used for many years to help people with heart conditions. This study focuses specifically on individuals who have heart failure. Heart failure is a condition where your heart struggles to pump enough blood around your body to meet its needs. This can lead to symptoms like breathlessness and tiredness. The aim of this study is to see how well digoxin helps people with heart failure who are being treated outside of a hospital setting.

The main goal is to find out if taking digoxin can reduce the chances of someone needing to go to the hospital because of their heart failure. This includes both planned hospital stays and urgent visits to the hospital for heart problems. The researchers also want to determine if digoxin can help prevent deaths caused by heart-related issues. By studying these factors, they hope to get a clearer picture of how beneficial digoxin is for chronic heart failure patients in their day-to-day lives.

Beyond these main points, the study will also look at other important aspects of health and well-being. This includes a patient's overall health, their quality of life, and how cost-effective the treatment is. They will also be carefully monitoring for any side effects of the medication and how it affects heart rate and other heart rhythms. This detailed approach aims to provide a comprehensive understanding of digoxin's role in managing heart failure.

Key takeaways

  • The DECISION study is investigating digoxin for heart failure.
  • It aims to reduce hospital visits and heart-related deaths.
  • It focuses on everyday life, not just hospital treatment.
  • Digoxin is an existing medicine, so it's a 'real-world' study.
  • The study includes adults of all ages, both men and women.
  • It also checks cost-effectiveness and quality of life.

Who may be eligible?

To be considered for this study, you would need to be an adult, meaning you are at least 18 years old. There is no upper age limit, so people of all adult ages are welcome to be considered.

Both men and women can take part in this research. The study is open to everyone, regardless of their gender.

Because this study is taking place in the Netherlands, participants would likely need to be living there or be able to easily access the study sites.

Quick self-check
  • Am I at least 18 years old?
  • Do I have a diagnosis of heart failure?
  • Am I willing to take the study medication (digoxin) if assigned?
  • Am I able to attend regular check-ups in the Netherlands?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular check-ups with your study team. You would receive the study medication, digoxin, if you are assigned to that group. The study will monitor your health closely, including how often you need hospital care for your heart failure. You would answer questions about your quality of life and your heart rate would be checked. The total length of your participation would depend on how long the study runs, but you would be kept informed at every stage.

Potential risks and benefits

Participating in this study might offer the benefit of receiving close medical attention and a widely used medication that has helped many people with heart conditions. However, like all medications, digoxin can have side effects, and these would be carefully monitored by the study team. Every effort would be made to ensure your safety and well-being. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Netherlands

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as strongly as it should. It doesn't mean your heart has stopped, but it might struggle to meet your body's needs, leading to symptoms like tiredness or breathlessness.

What is digoxin?

Digoxin is a medicine that has been used for many years to help the heart beat more strongly and sometimes to control an irregular heartbeat. It's often prescribed for heart conditions.

Why is this study important?

This study aims to get a clearer understanding of how well digoxin helps people living with heart failure outside of the hospital, specifically looking at reducing hospital visits and serious heart problems.

What is a 'Phase IV' study?

A Phase IV study means the medicine, digoxin in this case, is already approved and in use. This phase looks at the medicine's long-term effects, benefits, and any less common side effects in a larger group of patients.

Do I have to take part if I'm asked?

No, taking part in any medical study is completely voluntary. You should only join if you feel comfortable and understand everything clearly, and you can change your mind at any time.

How to find out more

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

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