Endothelin Role In COronary Microcirculation (ERICOM)

June 19, 2026 updated by: Liverpool University Hospitals NHS Foundation Trust

Determining the Role of Endothelin in Microcirculatory Function in Myocardial Ischaemia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary microvascular dysfunction (CMD) is increasingly recognised as a major cause of myocardial ischaemia and angina in patients without obstructive epicardial coronary artery disease. CMD is a key mechanism underlying ischaemia with non-obstructive coronary arteries (INOCA) and is associated with impaired quality of life, recurrent healthcare utilisation, and adverse cardiovascular outcomes.

Endothelin-1 (ET-1) is a potent endogenous vasoconstrictor peptide that has been implicated in endothelial dysfunction, vascular inflammation, and microvascular dysregulation. Elevated circulating ET-1 concentrations have been reported in patients with microvascular angina and may contribute to increased coronary microvascular resistance and impaired myocardial perfusion.

The ERICOM study is a prospective, single-arm mechanistic study designed to investigate the relationship between ET-1 and coronary microvascular dysfunction and to assess the effects of endothelin receptor antagonism on coronary microvascular function.

Participants with angina symptoms and evidence of coronary microvascular dysfunction undergo baseline clinical assessment, blood sampling for ET-1 measurement, and stress cardiovascular magnetic resonance (CMR) imaging. Participants receive bosentan therapy for four weeks followed by repeat stress CMR imaging. A subset of participants undergoes invasive coronary angiography with physiological assessment, including measurements of coronary flow reserve (CFR), index of microcirculatory resistance (IMR), fractional flow reserve (FFR), and resting full-cycle ratio (RFR).

The primary objective is to determine whether bosentan therapy improves coronary microvascular function as assessed by serial CMR-derived myocardial perfusion measurements. Secondary objectives include evaluating associations between ET-1 concentrations and CMD, assessing relationships between invasive and non-invasive measures of coronary microvascular function, and exploring mechanistic pathways linking endothelin signalling and coronary microvascular disease.

The study is sponsored by Liverpool University Hospitals NHS Foundation Trust and conducted in accordance with Good Clinical Practice, Research Ethics Committee approval, and Health Research Authority approval.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom
        • NHS University Hospitals of Liverpool Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. Age 18 years or older.
  3. Able and willing to provide written informed consent.
  4. Able and willing to adhere to study procedures and follow-up requirements.

Exclusion Criteria:

  1. Symptoms consistent with unstable angina, including:
  2. Angina at rest lasting more than 20 minutes.
  3. New-onset severe angina.
  4. Angina increasing in frequency, duration, or occurring at a lower threshold.
  5. Angina occurring following a recent myocardial infarction.
  6. Known significant coronary artery disease, defined as previous investigations demonstrating greater than 50% epicardial coronary artery stenosis.
  7. Uncontrolled hypertension, defined as clinic blood pressure greater than 140/90 mmHg despite treatment with three or more antihypertensive medications.
  8. Pregnancy or breastfeeding.
  9. Poorly controlled asthma as defined in the study protocol.
  10. Severe heart failure or symptoms of active heart failure.
  11. Significant chronic kidney disease, defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m².
  12. Clinical evidence of active infection at the time of recruitment.
  13. Significant liver disease, defined as Child-Pugh Class B or C liver disease (or worse than Child-Pugh Class A).
  14. Systolic blood pressure less than 90 mmHg at the time of recruitment.
  15. Previously documented allergy or hypersensitivity to endothelin receptor antagonists.
  16. Concurrent use of medications contraindicated with endothelin receptor antagonist therapy.
  17. Requirement for invasive coronary angiography for another clinical indication, including but not limited to valvular heart disease assessment or intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
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
Cardiac stress/perfusion MRI scan
Procedure: Invasive Coronary Angiogram
Invasive Coronary Angiogram with pressure wire assessments
Drug: Endothelin Receptor Antagonist
Participants will be given PO Bosentan 125 mg BD for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Myocardial Perfusion Reserve Index (MPRI) following Bosentan treatment
Time Frame: Baseline and 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Michael Fisher, NHS University Hospitals of Liverpool Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

July 31, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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