Bisoprolol in Patients After Myocardial Infarction with Preserved Ejection Fraction During Cardiac Rehabilitation

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What is this study about?

This clinical trial is studying people after a myocardial infarction, also called a heart attack, when the heart is still pumping well. The treatment being studied is bisoprolol, a beta-blocker medicine taken by mouth. Beta-blockers are medicines that slow the heart rate and reduce the heart’s workload. The purpose of the study is to see whether bisoprolol affects how people feel and recover during cardiac rehabilitation, which is a supervised program that helps people regain strength and improve heart health after a heart attack.

In this study, some people receive bisoprolol and some do not. The course of the study follows recovery over time during the rehabilitation program, which lasts about 3 months, with later follow-up up to 1 year. During this period, general health, daily well-being, and recovery after exercise are reviewed, along with symptoms such as tiredness, mood changes, and physical recovery. The study also looks at heart-related outcomes after rehabilitation.

1 start of the study

bisoprolol is given by mouth at a dose of 10 mg once daily.

You begin the study after joining it and follow the study plan for the full 3-month cardiac rehabilitation period.

2 during the 3-month cardiac rehabilitation period

You continue the assigned treatment during the 3-month rehabilitation period.

Your progress is checked during rehabilitation by measuring how you feel and how your body responds to exercise.

3 tests and questionnaires during rehabilitation

At the start of rehabilitation and again after 3 months, you complete the SF-36 questionnaire, which measures health-related quality of life. The study looks at the physical component summary (PCS) and mental component summary (MCS), which are summary scores for physical health and mental well-being.

Your exercise ability is measured with a cardiopulmonary exercise test (CPET), which is a test that checks how your heart, lungs, and muscles respond to exercise.

The study measures VO2 peak, which is the highest amount of oxygen your body uses during exercise.

The study measures VO2 at VT1, which is the oxygen level at the first point where breathing becomes harder during exercise.

The study measures peak load, which is the highest exercise level reached in watts.

The study measures time to exhaustion, which is how long you can continue a constant exercise load before stopping.

The study measures heart rate reserve, which is the difference between your resting heart rate and your highest heart rate during exercise.

The study records the reason why the exercise test is stopped.

4 additional checks during rehabilitation

At 1 month of rehabilitation, you complete the DASS-21 scale, which checks depression, anxiety, and stress.

At 2 months of rehabilitation, male participants complete the IIEF scale, which checks sexual function in men.

At 2 months of rehabilitation, female participants complete the FSFI scale, which checks sexual function in women.

5 end of rehabilitation and later follow-up

After 3 months of rehabilitation, the same quality-of-life and exercise measures are checked again to compare results with the start of the study.

The study also checks changes in PCS and MCS from the start of rehabilitation to 1 year after rehabilitation.

The study records all-cause mortality, which means death from any cause, and cardiovascular mortality, which means death related to the heart or blood vessels, after 3 months of rehabilitation.

Who Can Join the Study?

The person, or their legally authorized representative, must have given written informed consent before any study checks are done. This means they must sign a form saying they agree to take part.
The person must be 40 to 70 years old when they sign the consent form.
The person must be 72 hours to 7 days after a type 1 ST-elevation heart attack (STEMI) or non-ST-elevation heart attack (NSTEMI). A heart attack is a sudden loss of blood flow to the heart.
The person must have had a coronary angiography, which is an X-ray test that looks at the heart arteries, and this test must have shown blocked heart arteries caused by coronary artery disease.
The person must have been successfully treated during the same procedure with percutaneous coronary intervention (PCI), which is a procedure used to open narrowed or blocked heart arteries, often with a balloon and sometimes a stent.
After the heart attack, a heart ultrasound called transthoracic echocardiography must show a left ventricular ejection fraction of 40% or higher. Ejection fraction is the percentage of blood the main pumping chamber of the heart sends out with each beat.
The person must be willing to follow the 3-month cardiac rehabilitation program, which is a supervised program to help recovery after a heart attack.

Who Cannot Join the Study?

Any health problem or situation that, in the investigator’s judgment, could make it hard for the person to follow the study plan, study procedures, or follow-up visits.
Being incapacitated, meaning not able to make or understand decisions well enough to take part in the study.
Not being able to read, or being illiterate.
Any reason that makes beta-blocker therapy unsafe, including:
- Bradycardia, meaning a heart rate below 60 beats per minute.
- Second- or third-degree heart block, meaning a serious problem with the heart’s electrical signal.
- Sick sinus syndrome, meaning the heart’s natural pacemaker does not work properly.
- Sinoatrial block, meaning a block in the heart’s main electrical signal from the natural pacemaker.
- Acute heart failure, or being in a worsening heart failure episode that needs intravenous inotropic therapy, meaning medicine given through a vein to help the heart pump better.
- Cardiogenic shock, meaning a life-threatening condition where the heart cannot pump enough blood.
- Symptomatic hypotension, meaning low blood pressure that causes symptoms such as dizziness or fainting.
- Asymptomatic hypotension with a systolic blood pressure below 120 mmHg or a diastolic blood pressure below 60 mmHg, meaning low blood pressure even if there are no symptoms.
- Hypersensitivity to the active medicine or any ingredient in it, meaning an allergy or strong reaction.
- Severe bronchial asthma, meaning severe asthma affecting the airways.
- Severe peripheral arterial occlusive disease, meaning severe blockage of blood flow in the arms or legs, or severe Raynaud’s syndrome, meaning very poor blood flow to the fingers or toes.
- Untreated phaeochromocytoma, meaning a hormone-producing tumor of the adrenal gland that has not been treated.
- Metabolic acidosis, meaning the body has too much acid in the blood.
Any reason that makes CPET testing unsafe, where CPET means a cardiopulmonary exercise test, a test that checks heart and lung function during exercise, including:
- Unstable angina, meaning chest pain that is not under control.
- Symptomatic severe aortic stenosis, meaning a very tight heart valve that causes symptoms.
- Uncontrolled cardiac arrhythmias, meaning abnormal heart rhythms that are not well controlled.
- Uncontrolled heart failure, meaning heart failure that is not stable.
- Acute myocarditis or pericarditis, meaning sudden inflammation of the heart muscle or the lining around the heart.
- Physical disabilities that prevent the test from being done safely.
- Mental or cognitive impairment, meaning problems with thinking, understanding, or memory that make the test unsafe or unreliable.
Having another clear reason to need a beta-blocker besides the recent heart attack or high blood pressure, if the treating physician decides this is the case.
Already taking a beta-blocker and not being able to stop it or change to a non-beta-blocker medicine without slowly reducing the dose first.
Having a pacemaker or an implantable cardioverter defibrillator (ICD), which is a device placed in the body to help control heart rhythm.
Being in New York Heart Association class III or IV, meaning heart failure symptoms are severe and limit daily activity a lot.
Being pregnant, breastfeeding, or planning to become pregnant.
Being a woman who could become pregnant and not meeting the study’s pregnancy prevention requirements, including not having a negative pregnancy test when needed or not using a highly effective birth control method during the study period.
Having a positive pregnancy test during the study, which would lead to stopping study participation.
Taking part in another interventional trial with an investigational medicinal product or device, meaning another study testing a new medicine or device.

Where you can join this trial?

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Site Name	City	Country	Status
Uitsdrchqo Hxhedspnf Lyxirt	Leuven	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

Bisoprolol

Bisoprolol is a beta-blocker medicine taken by mouth. In this trial, it is being studied to see how it affects how people feel and recover after a heart attack when the heart is still pumping well. The study is looking at whether taking this medicine changes quality of life and recovery during a cardiac rehabilitation program.

Investigated diseases:

Acute myocardial infarction

Myocardial infarction with preserved ejection fraction – This is a type of heart attack in which part of the heart muscle is damaged because blood flow is blocked, but the heart’s pumping strength, measured as ejection fraction, remains within the normal range. It usually begins suddenly with injury to the heart muscle and may be followed by chest discomfort, shortness of breath, fatigue, or weakness. After the initial event, the heart tissue heals with scar formation, and some people may later have lasting symptoms such as reduced exercise tolerance or episodes of chest pain.

Trial ID:

2026-525475-96-00

Protocol code:

S71709

Trial Phase:

Therapeutic confirmatory (Phase III)

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Bisoprolol in Patients After Myocardial Infarction with Preserved Ejection Fraction During Cardiac Rehabilitation

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