Endothelin Role In COronary Microcirculation

NCT07670091 | Active Not Recruiting

• 1 other identifier: SP0323
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary microvascular dysfunction is an important cause of angina in patients who do not have significant blockages in the major coronary arteries. Previous studies suggest that endothelin-1, a naturally occurring substance that causes blood vessel constriction, may contribute to abnormalities in the coronary microcirculation. The ERICOM study aims to investigate whether treatment with bosentan, an endothelin receptor antagonist, can improve coronary microvascular function in patients with angina and evidence of coronary microvascular dysfunction. Participants undergo cardiovascular magnetic resonance (CMR) imaging before and after treatment, and some participants also undergo invasive coronary physiological assessment. The results of this study may improve understanding of the role of endothelin-1 in coronary microvascular dysfunction and help identify new treatment strategies for patients with angina and non-obstructive coronary artery disease.

Conditions

Coronary Microvascular Dysfunction (CMD); Angina Pectoris With Normal Coronary Arteriogram; Microvascular Angina

Keywords

ERICOM; Microvascular Angina; Ischemia With Non-Obstructive Coronary Arteries (INOCA); Coronary Microvascular Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in Myocardial Perfusion Reserve Index (MPRI) following Bosentan treatment

  Within-participant change in myocardial perfusion reserve index (MPRI) measured by stress cardiovascular magnetic resonance imaging before and after four weeks of Bosentan therapy.

  Baseline and 4 weeks

Study Arms (1)

Interventional group

EXPERIMENTAL

45 participants will undergo Cardiac MRI and invasive catheterization, and then given PO Endothelin Receptors Antagonists for 4 weeks. Participants will then have a repeat cardiac MRI.

Diagnostic Test: Cardiac MRI; Procedure: Invasive Coronary Angiogram; Drug: Endothelin Receptor Antagonist

Interventions

Cardiac MRI DIAGNOSTIC_TEST

Cardiac stress/perfusion MRI scan

Interventional group

Invasive Coronary Angiogram PROCEDURE

Invasive Coronary Angiogram with pressure wire assessments

Interventional group

Endothelin Receptor Antagonist DRUG

Participants will be given PO Bosentan 125 mg BD for 4 weeks.

Interventional group

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of symptomatic angina, defined as the presence of substernal chest pain or discomfort provoked by exertion or emotional stress and relieved by rest and/or glyceryl trinitrate (nitroglycerin).
• Age 18 years or older.
• Able and willing to provide written informed consent.
• Able and willing to adhere to study procedures and follow-up requirements.

You may not qualify if:

• Symptoms consistent with unstable angina, including:
• Angina at rest lasting more than 20 minutes.
• New-onset severe angina.
• Angina increasing in frequency, duration, or occurring at a lower threshold.
• Angina occurring following a recent myocardial infarction.
• Known significant coronary artery disease, defined as previous investigations demonstrating greater than 50% epicardial coronary artery stenosis.
• Uncontrolled hypertension, defined as clinic blood pressure greater than 140/90 mmHg despite treatment with three or more antihypertensive medications.
• Pregnancy or breastfeeding.
• Poorly controlled asthma as defined in the study protocol.
• Severe heart failure or symptoms of active heart failure.
• Significant chronic kidney disease, defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m².
• Clinical evidence of active infection at the time of recruitment.
• Significant liver disease, defined as Child-Pugh Class B or C liver disease (or worse than Child-Pugh Class A).
• Systolic blood pressure less than 90 mmHg at the time of recruitment.
• Previously documented allergy or hypersensitivity to endothelin receptor antagonists.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

NHS University Hospitals of Liverpool Group

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Microvascular Angina

Interventions

Endothelin Receptor Antagonists

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Michael Fisher

  NHS University Hospitals of Liverpool Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: August 1, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

GB (1)