Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)

NCT06600178 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 301805
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to that Sodium-glucose cotransporter 2 inhibitors treatment will improve Coronary Microvascular Disease with anginal symptoms associated with non-obstructive coronary disease in women. The main questions it aims to answer are: Aim 1: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves coronary microvascular disease in women with no evidence of epicardial obstructive coronary artery disease. Aim 2: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves angina symptoms and other quality of life measurements associated with the improvement of CFR. AIM 3: Identify the effect of Sodium-glucose cotransporter 2 inhibition on inflammation pathways and markers of systemic Research will compare Brezavvy to placebo Participants will:

• Take study drug or placebo for 12 weeks
• Stress Cardiac magnetic resonance imaging
• 12 lead electrocardiograms
• Complete questionnaires

Conditions

Angina Patients With Non-obstructive Coronary Artery Disease; Coronary Microvascular Disease; Coronary Microvascular Dysfunction (CMD)

Keywords

Angina; ANOCA; Non-obstructive Coronary Artery Disease; CMD; Non-Obstructive CAD; Chest Pain in Women

Outcome Measures

Primary Outcomes (1)

• Change in Coronary Flow Reserve

  Coronary flow reserve is calculated as the ratio of hyperemic myocardial blood flow to the resting myocardial blood flow using cardiovascular magnetic resonance myocardial perfusion imaging

  From enrollment to 12 weeks

Study Arms (2)

Active Drug Group

EXPERIMENTAL

Brezavvy 20mg oral tablet

Drug: Brezavvy 20Mg Oral Tablet

Placebo Group

PLACEBO COMPARATOR

placebo tablet

Drug: Placebo

Interventions

Brezavvy 20Mg Oral Tablet DRUG

Brezavvy 20mg oral

Active Drug Group

Placebo DRUG

Placebo tablet given to subject vs. active drug.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological Female sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Health

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (2)

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

• Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.

  PMID: 35078371 BACKGROUND

MeSH Terms

Conditions

Microvascular Angina; Angina Pectoris

Interventions

Tablets

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Patricia Rodriguez-Lozano, MD

  Uni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Rodriguez-Lozano, MD

CONTACT

434-982-1058; PR3GG@uvahealth.org

Shuo Wang

CONTACT

4349821058; VJR7CE@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double Blind, Randomized, single site

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: June 27, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)