Not recruiting

Study on Digoxin for Reducing Heart Failure Hospitalizations and Mortality in Outpatients with Chronic Heart Failure

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying heart failure, a condition where the heart doesn't pump blood as well as it should. The study is investigating the effects of a medication called digoxin, which is taken orally. The purpose of the study is to determine if low-level digoxin can reduce the number of hospital visits and the risk of death related to heart problems, compared to a placebo, in people with chronic heart failure.

Participants in the study will be monitored over a period of time to see how digoxin affects their heart health. The study will look at various outcomes, such as the number of times participants are hospitalized for heart failure, the number of urgent heart-related hospital visits, and overall heart-related deaths. Additionally, the study will assess the overall quality of life and any side effects experienced by participants taking digoxin.

The trial will also explore other aspects, such as the impact of digoxin on heart rate and the occurrence of a condition called atrial fibrillation (AF), which is an irregular and often rapid heart rate. The study aims to provide valuable insights into the effectiveness and safety of digoxin for managing chronic heart failure.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures of the trial. This study aims to evaluate whether low-level digoxin can reduce hospital visits and cardiovascular mortality in patients with chronic heart failure.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking your age, heart condition, and stability on current heart failure treatments. Blood tests may be performed to measure specific markers related to heart failure.
Step 3
Medication administration
If eligible, you will be assigned to receive either digoxin or a placebo. Digoxin is taken orally, and the dosage and frequency will be determined by the study team. The duration of administration will be specified during the trial.
Step 4
Regular follow-ups
Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits may include physical examinations, heart function tests, and discussions about any side effects you may experience.
Step 5
End of trial
The trial is expected to conclude by the end of 2025. At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on your heart condition and quality of life.

Who can join the trial?

8 criteria

Must be at least 18 years old.
Must be an outpatient with chronic heart failure (a condition where the heart doesn't pump blood as well as it should) and classified as NYHA II to ambulatory IV. NYHA is a scale that measures the severity of heart failure symptoms.
Must have a left ventricular ejection fraction (LVEF) of 50% or less. LVEF is a measurement of how much blood the left ventricle of the heart pumps out with each contraction.
Must have specific levels of NT-proBNP or BNP in the blood, which are markers used to diagnose heart failure. These levels must be measured within the last month:
- If you had a heart failure hospitalization within 1 year before joining the study, NT-proBNP must be 400 pg/mL or higher if you have normal heart rhythm, or 800 pg/mL or higher if you have atrial fibrillation (AF, a type of irregular heartbeat).
- If you had a heart failure hospitalization more than 1 year ago or never had one, NT-proBNP must be 600 pg/mL or higher if you have normal heart rhythm, or 1000 pg/mL or higher if you have AF.
- If you had a heart failure hospitalization within 1 year before joining the study, BNP must be 100 pg/mL or higher if you have normal heart rhythm, or 200 pg/mL or higher if you have AF.
- If you had a heart failure hospitalization more than 1 year ago or never had one, BNP must be 150 pg/mL or higher if you have normal heart rhythm, or 250 pg/mL or higher if you have AF.
- Must be stable for at least 14 days on guideline-recommended therapy, which means taking the recommended medications and doses as tolerated by the patient.

Who cannot join the trial?

1 criterion

Patients with a history of heart failure cannot participate. Heart failure is a condition where the heart doesn't pump blood as well as it should.

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Verified sites

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Universitair Medisch Centrum Groningen
Verified
Groningen, The Netherlands

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Investigated drugs

Digoxin is a medication used in this clinical trial to help manage chronic heart failure. It works by making the heart beat stronger and with a more regular rhythm. The goal of using digoxin in this study is to see if it can reduce the number of times patients with heart failure need to be hospitalized or visit the hospital urgently, as well as to see if it can lower the risk of death from heart-related issues. This trial is specifically looking at the effects of low-level digoxin in patients with chronic heart failure.

Digoxin

What is already known about the treatment

Digoxin – Digoxin is administered orally in the form of tablets and is used to treat heart failure. It is currently being studied in clinical trials to determine if low doses can reduce hospital visits and cardiovascular deaths in patients with chronic heart failure. The main therapeutic use of digoxin is to help the heart pump more efficiently, which can be beneficial for people with heart failure. At the molecular level, digoxin works by inhibiting an enzyme called Na+/K+ ATPase, which leads to an increase in calcium in heart cells, improving heart contraction. It is classified as a cardiac glycoside in pharmacology.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It often begins with the heart's inability to fill with enough blood or pump with enough force. As the condition progresses, fluid may build up in the lungs, liver, and other parts of the body, leading to symptoms like shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart's pumping ability continues to weaken, which can lead to more severe symptoms and complications. The progression of heart failure can vary, with periods of stability followed by episodes of worsening symptoms. It is a chronic condition that requires ongoing management to help control symptoms and improve quality of life.