Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association.
Connie W Tsao, Aaron W Aday, Zaid I Almarzooq...
https://pubmed.ncbi.nlm.nih.gov/35078371/Actively Recruiting
Led by University of Virginia · Updated on 2025-10-29
150
Participants Needed
1
Research Sites
30 weeks
Total Duration
Researchers are evaluating the effects of Sodium-glucose cotransporter 2 inhibitors SGLT2i on coronary microvascular disease CMD and anginal symptoms in women with non-obstructive coronary artery disease ANOCA. The study aims to test whether SGLT2i treatment improves coronary microvascular function, angina symptoms, quality of life, and reduces inflammation pathways in this population. This trial addresses an urgent need for therapies targeting CMD, which is more common in women with ischemic heart disease but less recognized and treated. Participants will be randomly assigned to receive either Brezavvy 20mg oral tablets or placebo for 12 weeks. The study is a single-center, randomized, double-blind, placebo-controlled phase 1 trial. Participants will undergo stress cardiac magnetic resonance imaging CMR and coronary flow reserve CFR measurements at baseline and after 12 weeks of treatment. Blood samples will be collected at baseline, 6 weeks, and 12 weeks to evaluate inflammation markers. Quality of life will be assessed through a series of questionnaires at baseline, 6 weeks, and 12 weeks. During the study, women with angina symptoms and CMD will have two stress CMR scans to measure changes in coronary blood flow. They will complete several health and symptom questionnaires and provide blood samples at three different times to monitor inflammation and cardiac function. Researchers will measure the primary outcome of change in coronary flow reserve from enrollment to 12 weeks. Safety and adherence will be monitored throughout the trial, which lasts about three months for each participant.
CONDITIONS
Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
P
Patricia Rodriguez-Lozano, MD
S
Shuo Wang
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University of Virginia
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Brezavvy (SGLT2i) | Placebo |
|---|---|---|
| What it is | An investigational oral SGLT2 inhibitor (Brezavvy 20 mg) being studied for coronary microvascular dysfunction and angina in women without obstructive coronary disease. | A placebo tablet used as the control comparison to the investigational drug. |
| Role in the trial | Active investigational arm intended to assess effect of SGLT2 inhibitor on CMD and symptoms. | Control arm receiving placebo to compare against the investigational intervention. |
| Primary use | Test whether SGLT2 inhibition improves coronary flow reserve and angina symptoms. | Serve as a control to isolate the effect of the investigational drug. |
| How it is given | Oral tablet of Brezavvy 20 mg taken by participants. | Matching placebo oral tablet administered the same way. |
| Evidence status | No published evidence yet in this population; clinical benefit remains experimental. | Placebo has no established therapeutic effect in CMD; provides background comparison. |
| Important risks | Unknown safety profile in this specific population; general SGLT2i risks apply but not reported in trial yet. | Placebo not expected to carry pharmacologic risks relevant to the trial. |
| Important limitations | Effectiveness in women with CMD is unproven; trial only tests short‑term change in flow reserve over 12 weeks. | Placebo does not inform how Brezavvy compares to existing treatments used in clinical practice. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - 12 weeks
Participants receive either the study drug Brezavvy 20mg oral tablet or a placebo for 12 weeks while continuing their standard care.
Weekly visits for medication dispensing and monitoring, plus stress CMR studies at the start and end of treatment
Duration - 12 weeks concurrent with treatment period
Participants undergo follow-up assessments including blood draws and quality of life questionnaires to evaluate treatment effects.
3 visits for blood draws and questionnaires at baseline, 6 weeks, and 12 weeks
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Connie W Tsao, Aaron W Aday, Zaid I Almarzooq...
https://pubmed.ncbi.nlm.nih.gov/35078371/Paul A Heidenreich, Biykem Bozkurt, David Aguilar...
https://pubmed.ncbi.nlm.nih.gov/35363499/University of Virginia
Lead Sponsor