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NCT Number: NCT06755801

Nebivolol ANOCA Treatment Randomized Trial

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.

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Key information

Conditions

ANOCA - Angina With Non-obstructive Coronary Arteries Angina Pectoris Cardiovascular Diseases Chest Pain Coronary Microvascular Dysfunction (CMD) Heart Diseases Microvascular Angina Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Objective 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.

Hypothesis Treatment with titrated nebivolol will result superior to placebo in symptoms control in patients presenting with coronary microvascular disease (CMD).

Study design Prospective, multicenter, controlled, double-blinded, randomized clinical trial.

Inclusion criteria

• Patients over 18 years old with symptoms or evidence of myocardial ischemia and coronary arteries without lesions or with epicardial lesions (<50% by visual estimation or FFR >0.80 / RFR >0.90), and

  • CFR ≤ 2.0 and/or IMR≥25 Exclusion criteria Life expectancy <1 year, inability to provide informed consent, severe valve disease, left ventricular ejection fraction <30%, clinical contraindication for betablockers treatment.

Treatment arms Randomization will be performed after invasive diagnostic of CMD:

Study group: Nebivolol • Patients will start with a dose of 5 mg every 24 hours. Biweekly dose adjustments will be performed during the first two months, increasing the dose (if tolerated with respect to heart rate, blood pressure, and symptoms) up to a maximum of 20 mg/24 hours.

Control group: Placebo

  • Patients will be treated with one tablet every 24 hours. Primary endpoint: The effectiveness of nebivolol treatment in improving angina symptoms was measured using the SAQ questionnaire after 6 months of treatment.

Secondary endpoints • Quality of life at 6 months.

  • Functional capacity at 6 months.
  • Major cardiac events at 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • History of surgical revascularization.
  • First-degree atrioventricular block or bifascicular block.
  • Presence of hemodynamically significant valvulopathy.
  • Presence of cardiomyopathy or congenital cardiac anomaly.
  • Severe renal insufficiency (eGFR < 30 ml/min).
  • Liver failure (history of cirrhosis or transaminase elevation > 3 times the upper limit of normal).
  • Pregnant or lactating women.

Treatment and study plan

Nevibolol

Drug

Beta-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

Drug

Placebo

Primary outcomes

  1. SAQ questionnaire

    Time frame: 6 months

    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.

Secondary outcomes

  1. Quality of Life Status using the EuroQOL questionnaire (EQ5D-5L)

    Time frame: 6 months

    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.

  2. the Brief Illness Perception Questionnaire (B-IPQ)

    Time frame: 6 months

    Changes in disease perception will also be recorded using the Brief Illness Perception Questionnaire (B-IPQ)

  3. anxiety and depression using PHQ-4

    Time frame: 6 months

    Quality of Life Status

  4. The treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)

    Time frame: 6 months

    Quality of Life Status

  5. Functional Capacity

    Time frame: 6 months

    Functional capacity in both groups will be objectively assessed by performing a baseline and 6-month exercise treadmill test (ergometry) according to the Bruce protocol. The evaluated parameter will be the total duration of maximum exercise (seconds).

  6. Major Cardiac Events

    Time frame: 6 months

    The presence of major cardiac events will be adjudicated by an Independent Events Committee. Major cardiac events are defined as death from any cause, acute myocardial infarction, and hospitalization due to unstable angina, stroke, or heart failure requiring hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

FERNANDO RIVERO, MD,PHD

CONTACT

[email protected]

+34 915202470.

Sponsors and collaborators

Lead sponsor

Spanish Society of Cardiology

Other

Registry information

Official study title

Microvascular Obstruction Treatment and Outcomes Randomized Study.

Acronym: MOTORS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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