Effect of Beta-blockers on Coronary Flow and Resistance in Patients With ANOCA

NCT06864234 | Recruiting Phase 4

• 1 other identifier: 2025/032
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether beta-blockers can improve coronary blood flow and reduce resistance in patients with angina and no obstructive coronary arteries (ANOCA). The main questions it aims to answer are:

• Do beta-blockers improve coronary blood flow in patients with ANOCA?
• Do beta-blockers reduce coronary microvascular resistance in these patients? Researchers will compare a beta-blocker to a placebo to see if the medication has measurable effects on coronary circulation. Participants will:
• Receive a beta-blocker or a placebo
• Undergo specialized heart tests (such as coronary flow and resistance measurements) before and after treatment.

Conditions

Coronary Arterial Disease (CAD); Angina (Stable); Microvascular Circulation

Keywords

angina; coronary artery disease; absolute coronary flow; continuous intracoronary thermodilution; Beta-blockers

Outcome Measures

Primary Outcomes (3)

• Change from baseline in the absolute coronary flow 10 minutes after administration of the intervention

  Absolute coronary flow will be measured using continuous intracoronary thermodilution

  10 minutes from the administration of the intervention

• Change from baseline in the absolute microvascular resistance 10 minutes after administration of the intervention

  Absolute microvascular resistance will be calculated using absolute coronary flow and distal coronary pressure

  10 minutes from the administration of the intervention

• Change from baseline in the microvascular resistance reserve (MRR) 10 minutes after administration of the intervention

  MRR will be calculated using absolute coronary flow, aortic pressure and distal coronary pressure

  10 minutes from the administration of the intervention

Secondary Outcomes (7)

• Change from baseline in the coronary flow reserve (CFR) 10 minutes after administration of the intervention

  10 minutes from the administration of the intervention

• Change from baseline in the absolute epicardial resistance 10 minutes after administration of the intervention

  10 minutes from the administration of the intervention

• Change from baseline in aortic pressure 10 minutes after administration of the intervention

  10 minutes from the administration of the intervention

• Change from baseline in distal coronary pressure 10 minutes after administration of the intervention

  10 minutes from the administration of the intervention

• Change from baseline in left ventricular end-diastolic pressure 10 minutes after administration of the intervention

  10 minutes from the administration of the intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

IV 0.9% NaCl (5 ml)

Drug: Saline (NaCl)

Beta-blocker

ACTIVE COMPARATOR

IV metoprolol (5 ml of 1 mg/ml solution for injection)

Drug: Metoprolol Tartrate

Interventions

Saline (NaCl) DRUG

IV 0.9% NaCl (5 ml)

Placebo

Metoprolol Tartrate DRUG

Metoprolol Tartrate (5 ml of 1 mg/ml solution for injection)

Beta-blocker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing diagnostic coronary angiography for suspected angina pectoris who are found to have ANOCA i.e. an FFR \>0.80 and no diameter stenosis \>50%
• Normal, TIMI 3 flow at angiography
• Stable haemodynamics

You may not qualify if:

• Clinical signs or symptoms of congestive heart failure
• Severe valvular heart disease requiring either surgical or percutaneous intervention
• History of coronary artery bypass grafting
• Tortuous coronary anatomy in which wire manipulation could be complex
• Heart rate \<60 beats per minute
• Systolic blood pressure \<100 mmHg
• Unable to give consent
• LVEF\<40%

Sponsors & Collaborators

• VZW Cardiovascular Research Center Aalst: lead

Study Sites (1)

OLV Cardiovascular Center Aalst

Aalst, Flanders, 9300, Belgium

RECRUITING

Related Publications (6)

• Erdogan D, Gullu H, Caliskan M, Ciftci O, Baycan S, Yildirir A, Muderrisoglu H. Nebivolol improves coronary flow reserve in patients with idiopathic dilated cardiomyopathy. Heart. 2007 Mar;93(3):319-24. doi: 10.1136/hrt.2006.091751. Epub 2006 Oct 25.

  PMID: 17065184 BACKGROUND

• Galderisi M, Cicala S, D'Errico A, de Divitiis O, de Simone G. Nebivolol improves coronary flow reserve in hypertensive patients without coronary heart disease. J Hypertens. 2004 Nov;22(11):2201-8. doi: 10.1097/00004872-200411000-00024.

  PMID: 15480106 BACKGROUND

• Koepfli P, Wyss CA, Namdar M, Klainguti M, von Schulthess GK, Luscher TF, Kaufmann PA. Beta-adrenergic blockade and myocardial perfusion in coronary artery disease: differential effects in stenotic versus remote myocardial segments. J Nucl Med. 2004 Oct;45(10):1626-31.

  PMID: 15471825 BACKGROUND

• Bottcher M, Czernin J, Sun K, Phelps ME, Schelbert HR. Effect of beta 1 adrenergic receptor blockade on myocardial blood flow and vasodilatory capacity. J Nucl Med. 1997 Mar;38(3):442-6.

  PMID: 9074535 BACKGROUND

• Togni M, Vigorito F, Windecker S, Abrecht L, Wenaweser P, Cook S, Billinger M, Meier B, Hess OM. Does the beta-blocker nebivolol increase coronary flow reserve? Cardiovasc Drugs Ther. 2007 Apr;21(2):99-108. doi: 10.1007/s10557-006-0494-7.

  PMID: 17235472 BACKGROUND

• Billinger M, Seiler C, Fleisch M, Eberli FR, Meier B, Hess OM. Do beta-adrenergic blocking agents increase coronary flow reserve? J Am Coll Cardiol. 2001 Dec;38(7):1866-71. doi: 10.1016/s0735-1097(01)01664-3.

  PMID: 11738286 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris; Coronary Artery Disease

Interventions

Sodium Chloride; Metoprolol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Central Study Contacts

Adriaan Wilgenhof, MD

CONTACT

+32 53 72 44 39; adriaan.wilgenhof@azorg.be

Thabo Mahendiran, MD

CONTACT

thabo.mahendiran@doctors.org.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 7, 2025
• Study Start: July 3, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)