To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.
Age 18 years or older.
Presence of stable angina symptoms, defined as compatible symptoms occurring at least once weekly in the last three months.
Absence of functionally significant epicardial coronary artery disease (FFR > 0.80).
Microvascular functional study showing CFR< 2,0 and/or IMR ≥ 25.
Allergy or contraindication to the use of beta-blockers.
Indication for beta-blocker treatment due to another pathology.
Ventricular dysfunction (LVEF < 45%).
Percutaneous coronary revascularization in the last 6 months.
Parallel
Nevibolol
DrugBeta-blockers are the first-line treatment for patients with stable angina secondary to classic epicardial atherosclerotic disease, where their clinical benefits are well-established (4). However, their efficacy has not yet been demonstrated in ANOCA patients with MVD, where beta-blockers are frequently used due to their physiological plausibility. Beta-blockers act by competitively inhibiting catecholamine receptors. The therapeutic benefits of beta-blockade in patients with stable angina are mediated by a reduction in myocardial oxygen demand. Myocardial oxygen demand depends on heart rate, contractility, and left ventricular wall tension, all of which are reduced with beta-adrenergic blockade. The reduction in wall tension is partly mediated by the antihypertensive action of these drugs. The decrease in heart rate occurs both at rest and during sympathetic activation such as exercise or stress. The negative inotropic effect of these drugs also contributes to reducing myocardial oxyg
Placebo
DrugPlacebo
SAQ questionnaire
The pre-specified primary outcome criterion is the improvement in angina severity assessed by the Seattle Angina Questionnaire (SAQ SS - Summary Score) at 6 months from the start of treatment compared to baseline. It will be evaluated by the mean difference in change within the same patient in SAQ between the two groups at 6 months of treatment. The SAQ is a validated self-administered scale that allows assessment of angina severity, frequency, quality of life, and functional limitation. It is the most commonly used and validated patient-reported outcome measure for angina. The SAQ provides a scale for evaluating the severity of angina that has been shown to be valid, reproducible, and sensitive to changes.
Quality of Life Status using the EuroQOL questionnaire (EQ5D-5L)
Patient's quality of life in both treatment groups will be assessed using the EuroQOL questionnaire (EQ5D-5L). The EQ5D-5L is the most widely used instrument for assessing health-related quality of life.
the Brief Illness Perception Questionnaire (B-IPQ)
Changes in disease perception will also be recorded using the Brief Illness Perception Questionnaire (B-IPQ)
anxiety and depression using PHQ-4
Quality of Life Status
The treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Quality of Life Status
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
