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Not yet recruiting NCT06755801

Nebivolol ANOCA Treatment Randomized Trial

Phase III Interventional ANOCA - Angina With Non-obstructive Coronary Arteries Coronary Microvascular Dysfunction (CMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nevibolol, Placebo.
Who it may be relevant to
Registry conditions: ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Microvascular Obstruction Treatment and Outcomes Randomized Study.

Overview

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.

Detailed description

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.

Interventions

  • Drug Nevibolol
    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 m
  • Drug Placebo
    Placebo

Primary outcome measures

  • SAQ questionnaire [Time frame: 6 months]
Secondary outcome measures (6)
  • Quality of Life Status using the EuroQOL questionnaire (EQ5D-5L) [Time frame: 6 months]
  • the Brief Illness Perception Questionnaire (B-IPQ) [Time frame: 6 months]
  • anxiety and depression using PHQ-4 [Time frame: 6 months]
  • The treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9) [Time frame: 6 months]
  • Functional Capacity [Time frame: 6 months]
  • Major Cardiac Events [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06755801 · sec1589634

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗