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

Launched by UNIVERSITY OF VIRGINIA · Sep 12, 2024

Keywords

ClinConnect Summary

The STRONG clinical trial is studying how a medication called Sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) can help women with angina, which is chest pain caused by reduced blood flow to the heart, particularly those who do not have blockages in their main heart arteries. The trial aims to find out if this treatment can improve heart function, lessen angina symptoms, and enhance overall quality of life for women suffering from a specific condition known as Coronary Microvascular Disease (CMD).

To participate in the trial, women aged 18 and older who have experienced symptoms of chest pain and have been referred for heart evaluation may be eligible, provided they show no major blockages in their heart arteries. Participants will receive either the study medication or a placebo (a non-active pill) for 12 weeks. They will also undergo tests like heart imaging and complete questionnaires about their symptoms and quality of life. It’s important to note that certain health conditions and recent medical history may prevent someone from taking part in the study. If you're interested, please consult with your healthcare provider for more information about eligibility and the potential benefits of participating.

Gender

FEMALE

Eligibility criteria

• 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 \< 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 rates\<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