- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533747
PRECISE Phenotyping to Guide Therapies for Coronary Microvascular Dysfunction (PRECISE-CMD)
Some people experience chest pain and shortness of breath, but when they have tests, no blockages are found in their main heart arteries. The most common cause of symptoms is related to abnormalities in the small blood vessels, also known as 'small vessel angina' or Coronary Microvascular Dysfunction (CMD). Currently, the diagnosis of CMD requires additional measurements of blood flow in the heart vessel during a minimally invasive procedure known as a coronary angiogram.
CMD affects many people and can lead to repeated hospital visits and a lower quality of life, and diagnosing the condition leads to better patient outcomes. However, there are still no widely available, proven treatments for this condition and therefore several patients remain symptomatic.
This study aims to find better ways to treat CMD, especially by understanding how the heart uses energy and how this might relate to symptoms.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Haseeb Rahman, MA BMBCh MRCP PhD
- Phone Number: United Kingdom
- Email: haseeb.rahman@kcl.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Angina with non-obstructive coronary arteries
Exclusion Criteria:
- Significant epicardial coronary stenoses
- Inability to carry out bike exercise
- Contra-indication to adenosine administration
- Insulin usage with frequent hypoglycaemic episodes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Empagliflozin Therapy Arm
Empagliflozin 10mg OD
|
Drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial Perfusion Reserve
Time Frame: 8 weeks
|
Perfusion Cardiac Magnetic Resonance Imaging
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26/LO/0222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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