Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Effects of Digoxin in Modern Heart Failure Treatment

This study is investigating a well-known medicine called Digoxin, used to treat heart failure. Researchers want to understand how it works in people who are also receiving today's standard heart failure treatments. They will measure how much oxygen your body uses during exercise, which tells them about your fitness and heart health. They will also use heart scans (echocardiograms) to see how effectively your heart muscle is working. This is a Phase IV study, meaning Digoxin is already approved, but scientists are gathering more information about its long-term effects and how it fits into current medical care for heart failure.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Unidade Local De Saude De Sao Jose E.P.E.

Enrolment target

Start

13 Sep 2024

Heart Failure

What is this study about?

This study is looking at how a medicine called Digoxin helps people with heart failure when they are also having other modern treatments. Heart failure is a condition where your heart doesn't pump blood around your body as well as it should. Digoxin is a medicine that has been used for a long time to help the heart pump more strongly and regulate heart rhythm. The researchers want to understand how Digoxin works specifically in today's medical landscape, where many other effective treatments for heart failure are also available.

The main things the researchers want to find out are how well your body uses oxygen when you exercise and how efficiently your heart muscles are working. They will measure your 'peak oxygen consumption' using a special exercise test on a bike or treadmill. This shows how fit your heart and lungs are. They will also use detailed heart scans, called echocardiograms, to look at how your heart muscle is moving and whether it's pumping blood effectively.

By carefully measuring these things, and other aspects like hospital stays, symptoms, and blood tests, the study aims to give doctors a clearer picture of how Digoxin helps people with heart failure. This information can then help doctors make the best treatment choices for their patients.

Key takeaways

This study explores Digoxin's role in modern heart failure treatment.
It measures heart function and fitness using exercise tests and scans.
The study helps doctors understand Digoxin's benefits for future patients.
It involves visits, tests, and taking either Digoxin or another medication.
Participation lasts approximately 24 weeks (6 months).

Who may be eligible?

To be part of this study, you need to be at least 18 years old. The study is open to both men and women.

Beyond these basic requirements, the research team will check other health factors to make sure the study is safe and right for you. They will need to confirm that you have heart failure and that Digoxin is a suitable treatment within the study's specific criteria. Your doctor and the study team will discuss all the details with you to see if you qualify.

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 able to visit a clinic regularly for appointments?
Are you willing to undergo exercise tests and heart scans?
Are you comfortable taking study medication as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have several visits to the clinic over a period of about six months (24 weeks). During these visits, you might have some special tests. These include exercise tests where you'll pedal a bike or walk on a treadmill while connected to monitors (called a Cardiopulmonary Exercise Test) to see how well your heart and lungs work. You will also have heart scans (echocardiograms) to get detailed pictures of your heart.

Blood and urine samples will be taken regularly to check different markers of your health. You'll also be asked to fill out questionnaires about how you are feeling and your quality of life. The study involves taking one of the study medications, either Digoxin or a charcoal mixture, as prescribed by the study doctors. Throughout the study, your health will be carefully monitored by the research team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from being in this study, but your participation could help doctors understand more about treating heart failure, which might help others in the future. Potential risks could include side effects from the study medication, discomfort from tests like blood draws or exercise tests, or inconvenience from clinic visits. 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
Portugal

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood around your body as efficiently as it should. It can lead to symptoms like breathlessness and tiredness.

What is Digoxin?

Digoxin is a medicine that can help your heart pump more strongly and regulate irregular heartbeats, often used for heart failure.

What is a Cardiopulmonary Exercise Test?

It's an exercise test on a bike or treadmill while connected to monitors, to see how well your heart and lungs work together.

What is an Echocardiography?

It's a type of ultrasound scan that uses sound waves to create moving pictures of your heart, showing how it's pumping.

Will I know if I'm getting Digoxin or not?

In some studies, participants may not know which treatment they are receiving to ensure fair results. The study team can explain this further.