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Could a diabetes drug ease chest pain in women with hidden heart disease?

NCT ID NCT06600178

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tests whether a drug called Brezavvy (an SGLT2 inhibitor) can improve blood flow in the tiny vessels of the heart and reduce chest pain in women who have angina but no blocked major arteries. 150 women will take either the drug or a placebo for 12 weeks and undergo heart scans and questionnaires. The goal is to see if this treatment can help manage a condition that often goes undiagnosed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Brezavvy (SGLT2 inhibitor)
What this could lead to
If successful, this could point toward a new treatment option for women with chest pain caused by small heart vessel problems, improving their quality of life.
What could go wrong
This is an early Phase 1 trial with only 150 participants, so results may not apply to everyone. The drug may not improve symptoms or could have side effects not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • Female sex. * Age ≥18 years. * Willing and able to provide written informed consent. * Signs and symptoms of suspected ischemia prompted referral for further evaluation by cardiac catheterization or CCTA within two years of consent. * No evidence of obstructive epicardial CAD (stenosis \<50%) of a major epicardial vessel or an FFR ≤0.80 by invasive catheterization or CCTA. Patients who have not undergone cardiac catheterization of CT angiogram within the last 2 years for chest pain can be scheduled for a screening CT angiogram of the coronary arteries to confirm eligibility. * Diagnosis of CMD defined by CFR \&lt; 2 by CMR * Never on SGLT2i Exclusion Criteria: * History of non-ischemic cardiomyopathy LVEF \<40% or hypertrophic cardiomyopathy. * History of congestive heart failure, severe pulmonary disease, liver disease * History of acute coronary syndrome (ACS) within previous 30 days * Stroke within the last 180 days or intracranial hemorrhage at any time. * Severe valvular disease * Life expectancy \<3 years, due to non-cardiovascular comorbidity. * Pregnancy or women who are breast-feeding * Type 1 diabetes mellitus * Symptomatic hypotension or systolic BP \>95 mmHg on 2 consecutive measurements * Active malignancy requiring treatment at the time of visit * Severe (eGFR \<30 mL/min/1.73 m2 by CKD-EPI), unstable, or rapidly progressing renal disease at the time of randomization * History of recurrent UTI/bladder/kidney infections * Asthma with ongoing wheezing * Known or suspected broncho-constrictive or bronchospastic lung disease (ARDS, emphysema) * Greater than first degree heart block * Implanted cardiac device * Profound sinus bradycardia (heart rate \<40 beats per minute) * Atrial fibrillation or supraventricular arrhythmias at time of imaging * Known intolerance of nitrates (other than hypotension) * History of reaction to iodinated contrast agents

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UVA Health

    RECRUITING

    Charlottesville, Virginia, 22908, United States

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