BridgeMD
The impact of beta-blocker therapy on quality of life and rehabilitation outcomes in patients after myocardial infarction with preserved ejection fraction
EU CTIS ID: 2026-525475-96-00
What this study is testing
To test the hypothesis that beta-blocker therapy negatively impacts health-related quality of life in post-AMI patients with LVEF undergoing a CR program. Specifically, it is hypothesized that patients not receiving beta-blocker therapy will demonstrate superior SF-36 Physical Component Summary (PCS) or Mental Component Summary (MCS) scores after completing a 3-month CR program, compared to patients receiving beta-blocker therapy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
- Incapacitated persons
- No capability to read or illiterate patients
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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.
- Incapacitated persons
- No capability to read or illiterate patients
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.