A study testing the reduction of heart failure drug combination in patients with heart failure in remission

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What is this study about?

This study is looking at heart failure in remission, which is a condition where the heart’s pumping ability has improved and returned to normal levels after previously being weakened. Heart failure in remission means that the heart has recovered to function normally, the heart chambers have returned to normal size, certain blood markers are at low levels, patients can perform daily activities without problems, and their condition has been stable. The study will use several medications that are commonly prescribed for heart failure, including lisinopril, empagliflozin (also known as Jardiance), bisoprolol fumarate, and spironolactone. These medications work in different ways to help the heart function better and are usually taken by mouth as tablets.

The purpose of this study is to find out if it is safe and possible to reduce or partially withdraw heart failure medications in patients whose hearts have recovered, compared to continuing all medications at the same doses. This will help doctors understand whether patients who have recovered from heart failure can safely take lower doses of their medications or stop some of them. The study will compare two groups of patients: one group will have some of their heart failure medications reduced while the other group will continue taking all their medications as before.

During the study, patients will be followed for up to 24 months. The study will measure several important things to see how well the heart is working and how patients are doing overall. Doctors will use heart ultrasound scans to check if the heart chambers change in size and will measure blood markers to monitor the heart’s condition. They will also track whether patients need to restart or increase their heart failure medications, how patients feel and function in their daily lives, and whether any serious health problems occur. The study will begin enrolling patients in October 2025 and is expected to be completed by March 2028.

1 Baseline assessment and randomization

At the start of the trial, your current heart condition will be assessed. This includes measuring your left ventricular end-systolic volume index, which is a measurement of the size of the main pumping chamber of your heart when it contracts.

Your NT-proBNP level will be measured. This is a substance in your blood that indicates how well your heart is working. At this stage, your level should be at or below 250 pg/mL.

An echocardiography examination will be performed. This is an ultrasound scan of your heart that allows doctors to see its structure and function.

Your quality of life will be assessed using the KCCQ-12 questionnaire, which measures how heart failure affects your daily activities.

You will be randomly assigned to one of two groups: one group will continue taking all current heart failure medications, and the other group will gradually reduce some of these medications.

2 Treatment phase

If you are assigned to the group that continues current treatment, you will keep taking your heart failure medications as prescribed. These may include lisinopril (taken by mouth as a tablet), empagliflozin (taken by mouth as a film-coated tablet), bisoprolol fumarate (taken by mouth as a tablet), and spironolactone (taken by mouth as a film-coated tablet).

If you are assigned to the group with medication reduction, some of your heart failure medications will be gradually decreased under medical supervision. The specific medications, doses, and timing of the reduction will be determined by the trial protocol.

You must have been taking at least three types of heart failure medications for at least 6 months before entering the trial, and each medication must have been at the highest dose you can tolerate.

The treatment phase will continue for the duration of the trial, which is estimated to last until March 2028.

3 Regular monitoring visits

Throughout the trial, you will attend regular monitoring visits to check your heart function and overall health.

At these visits, your left ventricular end-systolic volume index will be measured using echocardiography to detect any changes in heart size. An increase of more than 20% from your starting measurement is one of the main outcomes being monitored.

Your NT-proBNP blood levels will be checked regularly. An increase to more than 500 pg/mL is one of the main outcomes being monitored.

Your quality of life will be assessed using the KCCQ-12 questionnaire to see if there are any changes in how you feel and function in daily life.

Any hospitalizations for any reason will be recorded.

If you are in the medication reduction group, the trial team will monitor whether you need to restart or increase any heart failure medications, including starting a type of medication called a loop diuretic, which helps your body remove excess fluid.

4 End of trial assessment

At the end of the trial, a final comprehensive assessment of your heart function will be performed.

This will include a final echocardiography examination to measure your left ventricular end-systolic volume index.

A final blood test will measure your NT-proBNP level.

You will complete a final KCCQ-12 questionnaire to assess your quality of life.

All information collected throughout the trial will be analyzed to determine whether reducing heart failure medications is safe and feasible for patients whose heart failure is in remission.

Who Can Join the Study?

To join this clinical trial, you must meet all of the following requirements:

You must be an adult who is 18 years of age or older
You must have heart failure in remission, which means your heart failure has improved and your heart is now working better. This includes:
- Your heart’s ejection fraction (the amount of blood your heart pumps out with each beat) has improved to above 50%
- The size of your heart’s left ventricle (the main pumping chamber of your heart) has returned to normal
- Your NT-proBNP level (a blood test that measures stress on your heart) is 250 pg/mL or lower
- You have normal ability to perform daily activities
- Your condition has been stable
You must be taking at least 3 different heart failure medications from the following types:
- ACEi (a medicine that relaxes blood vessels), ARB (another type of medicine that relaxes blood vessels), or ARNI (a combination medicine that helps your heart work better)
- BB (beta-blocker, a medicine that slows your heart rate and reduces strain on your heart)
- MRA (a medicine that helps remove extra fluid) or SGLT2i (a medicine that helps your heart and kidneys)
Each of your heart failure medications must be at the highest dose you can tolerate and has been stable for at least 6 months before joining the study

Who Cannot Join the Study?

Age restrictions – The study may not accept patients outside certain age groups, so please check if your age falls within the acceptable range for participation
Pregnancy or breastfeeding – Women who are pregnant, planning to become pregnant, or currently breastfeeding may not be able to participate in this study
Other active heart conditions – If you have heart failure that is not in remission (meaning your heart failure is not currently under control or improved), you cannot participate
Severe kidney or liver disease – Having serious problems with your kidneys or liver that are not well controlled may prevent you from joining the study
Recent heart attack or stroke – If you have had a heart attack or stroke within a recent time period, you may not be eligible
Inability to follow study requirements – If you cannot attend regular study visits, take medications as directed, or follow the study plan, you may not be able to participate
Participation in other studies – Being enrolled in another clinical trial at the same time may exclude you from this study
Known allergies – Having severe allergies to the medications being studied would prevent participation
Uncontrolled blood pressure – If your blood pressure is very high and not controlled with treatment, you may not qualify
Life-threatening conditions – Having other serious medical conditions that could affect your safety during the study may be a reason for exclusion

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Jessa Ziekenhuis	Hasselt	Belgium
Ziekenhuis Oost Limburg	Genk	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.10.2025

Trial locations

Investigated drugs:

Guideline-directed medical therapy for heart failure is a combination of medications that doctors use to treat heart failure according to established medical guidelines. These medicines work together to help your heart pump blood more effectively, reduce strain on your heart, and improve your symptoms. In this study, researchers are looking at whether it is safe to reduce the amount of these heart failure medications in patients whose condition has improved and is now in remission. The study will compare patients who continue taking their full dose of heart failure medications with patients who gradually reduce their medication doses.

Investigated diseases:

Cardiac failure

Heart Failure in Remission – Heart failure in remission is a condition where a patient previously diagnosed with heart failure has experienced significant improvement in heart function and symptoms. The heart’s ability to pump blood has recovered to a degree where the typical signs of heart failure, such as shortness of breath and fluid retention, are no longer present or are minimal. This remission state occurs after successful medical management, which has allowed the heart muscle to recover and the heart chambers to return closer to normal size. Despite the improvement, the heart may still have some underlying vulnerability and requires careful monitoring. The condition is characterized by normalized or near-normalized measurements of heart function, including left ventricular volume and stable biomarker levels such as NT-proBNP. Patients in remission continue to be monitored for any signs of the heart enlarging again or symptoms returning, which would indicate a relapse of heart failure.

Trial ID:

2025-522560-32-01

Protocol code:

Z-2025058

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study testing the reduction of heart failure drug combination in patients with heart failure in remission

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?