Nebivolol ANOCA Treatment Randomized Trial

NCT06755801 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: sec1589634
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ANOCA - Angina With Non-obstructive Coronary Arteries; Coronary Microvascular Dysfunction (CMD)

Keywords

Coronary Microvascular Disease; Betablockers; Angina

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

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

  6 months

• the Brief Illness Perception Questionnaire (B-IPQ)

  6 months

• anxiety and depression using PHQ-4

  6 months

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

  6 months

• Functional Capacity

  6 months

Study Arms (2)

Active treatment group

EXPERIMENTAL

Nevibolol tratment

Drug: Nevibolol

Control group

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

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

Active treatment group

Placebo DRUG

Placebo

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Society of Cardiology: lead

MeSH Terms

Conditions

Microvascular Angina; Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

FERNANDO RIVERO, MD,PHD

CONTACT

+34 915202470.; hemodinamicaprincesa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology Department. H. U. de la Princesa.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: January 1, 2025
• Study Start: April 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12