Bisoprolol Effects on Quality of Life and Cardiac Rehabilitation Outcomes in Post-Myocardial Infarction Patients with Preserved Ejection Fraction
- Trial ID
- 2026-525475-96-00
- Protocol
- S71709
- Sponsor
- UZ Leuven
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate whether beta-blocker therapy adversely affects health-related quality of life in patients after myocardial infarction with preserved ejection fraction during a 3-month cardiac rehabilitation program. Clinical relevance is assessed by comparing SF-36 Physical Component Summary and Mental Component Summary scores between patients receiving and not receiving beta-blocker therapy. Secondary objectives include assessment of individual SF-36 domains, changes in health-related quality of life across early recovery, the rehabilitation period, and long-term follow-up, psychological distress measured by DASS-21, sexual function measured by IIEF and FSFI, and rehabilitation performance outcomes including maximal and submaximal aerobic capacity, peak workload, quadriceps strength, chronotropic response, and endurance capacity. Additional objectives include evaluation of exercise test termination reasons, within-patient changes in SF-36 scores over time, and all-cause and cardiovascular mortality after the rehabilitation program.
Participants
The sponsor did not provide the total number of participants or detailed selection information for the study population. The trial population included patients of both sexes, aged 40 to 70 years, who were 72 hours to 7 days post–type 1 STEMI or NSTEMI, had obstructive coronary artery disease treated with percutaneous coronary intervention during the index procedure, and had a left ventricular ejection fraction of at least 40% after the myocardial infarction. Participants were required to provide written informed consent and to be willing to comply with a 3-month cardiac rehabilitation program. No additional information on lifestyle considerations was provided.
Plans and Procedures
The trial is an interventional study evaluating bisoprolol therapy in patients after myocardial infarction with preserved ejection fraction during a 3-month cardiac rehabilitation program. The overall trial duration is planned from June 2026 to October 2026. After the inclusion and screening visit, eligible participants undergo baseline assessments before starting rehabilitation. Follow-up visits are performed during the rehabilitation period to assess health-related quality of life, exercise capacity, and other prespecified outcomes. An end-of-study visit is conducted after completion of the 3-month program to compare changes from baseline and to record final trial outcomes. Expected participant involvement is approximately 3 months, with additional assessments extending to 1 year of cardiac rehabilitation for selected outcomes. Early termination may occur in the event of withdrawal of consent, non-compliance with the rehabilitation program, loss to follow-up, or other circumstances preventing completion of the planned study procedures.
Treatment
Bisoprolol was administered as an oral treatment at a dose of 10 mg. The product was given by mouth once daily. The pharmaceutical form was not specified. The same active treatment was listed repeatedly in the study records, with no additional non-experimental comparator, placebo, or standard-of-care treatment described in the source data. No further dosing modifications, administration procedures, or compliance monitoring methods were specified.
Efficacy
Efficacy will be assessed by comparing group differences between patients taking beta blockers and those not taking beta blockers after 3 months of cardiac rehabilitation using the SF-36 scale, with evaluation of the Mental Component Summary (MCS) and Physical Component Summary (PCS) domains as primary efficacy endpoints. Secondary efficacy assessment will include group differences in all individual SF-36 domains, including physical functioning, role physical, bodily pain, general health, vitality, role emotional, and mental health, after 3 months of cardiac rehabilitation. Additional efficacy outcomes will include absolute and relative changes in VO2 peak, VO2 at VT1, peak load, time to exhaustion during a constant-load exercise test performed at VT1, percent heart rate reserve, and one-repetition maximum test performance in leg press from the start of cardiac rehabilitation to 3 months. Time to exhaustion and percent heart rate reserve will also be assessed at the start and after 3 months of cardiac rehabilitation. The reason for CPET termination will be evaluated at baseline and after 3 months of cardiac rehabilitation based on CPET data. Changes in MCS and PCS will also be assessed from hospital discharge to the start of cardiac rehabilitation, from the start of cardiac rehabilitation to 3 months, and from the start of cardiac rehabilitation to 1 year. Additional assessments include DASS-21 domains for depression, anxiety, and stress at 1 month of cardiac rehabilitation, IIEF for male participants at 2 months, and FSFI for female participants at 2 months. Within-patient changes in PCS and MCS from the start of cardiac rehabilitation to 1 year after cardiac rehabilitation and all-cause and cardiovascular mortality after 3 months of cardiac rehabilitation will also be evaluated.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Between 40 and 70 years of age at the time of signing the Informed Consent Form
- Participant is 72 hours to 7 days post–type 1 STEMI or NSTEMI and has undergone coronary angiography demonstrating obstructive coronary artery disease and has been successfully treated with percutaneous coronary intervention during the index procedure
- Transthoracic echocardiography performed following the index myocardial infarction demonstrates a left ventricular ejection fraction ≥ 40%.
- Willingness to comply to the 3-month cardiac rehabilitation program in the University Hospitals Leuven
Exclusion Criteria
- Any condition that, in the Investigator’s judgment, may compromise the participant’s ability to comply with the Trial protocol, procedures, or follow-up requirements.
- Presence of any contraindication to beta-blocker therapy, including a. Bradycardia (heart rate < 60 bpm) b. Second or third degree heart block c. Sick sinus syndrome d. Sinoatrial block e. Acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy f. Cardiogenic shock g. Symptomatic hypotension h. Asymptomatic hypotension when systolic blood pressure < 120 mmHg or diastolic blood pressure < 60 mmHg i. Hypersensitiviy to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics j. Severe bronchial asthma k. Severe forms of peripheral arterial occlusive disease or severe forms of Raynaud’s syndrome l. Untreated phaeochromocytoma m. Metabolic acidosis
- Presence of any contraindication to CPET testing, including a. Unstable angina b. Symptomatic severe aortic stenosis c. Uncontrolled cardiac arrhythmias d. Uncontrolled heart failure e. Acute myocarditis or pericarditis f. Physical disabilities g. Mental or cognitive impairment
- Presence of any indication for beta-blocker therapy other than post–myocardial infarction or hypertension (for which an alternative antihypertensive can be prescribed), as determined by the treating physician
- Participants currently receiving beta-blocker treatment who cannot discontinue or switch to a non–beta-blocker therapy without tapering. Examples of doses generally considered acceptable for direct discontinuation include: bisoprolol 2.5 mg, nebivolol 5 mg, atenolol/metoprolol 50 mg and propranolol 40 mg.
- Participants with a pacemaker or implantable cardioverter defibrillator (ICD)
- New York Heart Association (NYHA) functional class III–IV
- Female who is pregnant, breast-feeding or intends to become pregnant. Pregnancy is contraindicated and therefore discouraged in the period following myocardial infarction as part of standard of care. In case of women of childbearing potential, defined as women with regular or irregular menstruation who have not met the criteria for postmenopausal status, i.e. spontaneous amenorrhea for at least 12 consecutive months without an alternative medical cause, confirmed by FSH > 40 IU/L; or spontaneous amenorrhea for at least 24 consecutive months without FSH confirmation; or bilateral oophorectomy; or hysterectomy, the following requirements apply: a. A pregnancy test (hcg in urine) is required at screening and prior to randomization. At Visits 3 and 8, the treating physician will ask about possible pregnancy or delayed menstrual period. During CR, participants self-report monthly on pregnancy and menstrual status. Any suspected pregnancy will be confirmed by a urine test. A positive result will lead to discontinuation from the study. b. Female participants of childbearing potential must use a highly effective contraceptive method during the treatment period and until the end of relevant systemic exposure. Highly effective methods (failure rate <1% per year) include: combined or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner; or sexual abstinence. This advice is part of standard care following a myocardial infarction
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Incapacitated persons
- No capability to read or illiterate patients
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Recruiting | 01 Jun 2026 | 160 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
BISOPROLOL | Test | — | ORAL | 10 | 56 | SUB13096MIG |
BISOPROLOL | Test | — | ORAL USE | 10 | 56 | SUB13096MIG |
BISOPROLOL | Test | — | ORAL | 10 | 56 | SUB13096MIG |
BISOPROLOL | Test | — | ORAL | 10 | 56 | SUB13096MIG |