Clinical trial NCT06755801: Nebivolol ANOCA Treatment Randomized Trial
Official title: Microvascular Obstruction Treatment and Outcomes Randomized Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: ANOCA - Angina With Non-obstructive Coronary Arteries
Coronary Microvascular Dysfunction (CMD)
Keywords: Coronary Microvascular Disease
Betablockers
Angina
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: SAQ questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life Status using the EuroQOL questionnaire (EQ5D-5L)
timeFrame: 6 months
measure: the Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: 6 months
measure: anxiety and depression using PHQ-4
timeFrame: 6 months
measure: The treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: 6 months
measure: Functional Capacity
timeFrame: 6 months
measure: Major Cardiac Events
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: