Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called engagliflozin affects patients who are at risk of developing heart failure and have high blood pressure. The study will involve 120 participants aged between 40 and 74 who are currently taking medication for high blood pressure and have specific heart measurements that suggest they are at risk of heart issues. Participants will be randomly assigned to either receive engagliflozin or a placebo (a sugar pill with no active medication) for six months. The main goal is to see how this medication impacts heart function, specifically focusing on the size and health of the left atrium, which is an important part of the heart.

To be eligible for this trial, participants need to be between 40 and 74 years old, have high blood pressure under control with medication, and show certain heart indicators that could suggest early signs of heart failure. However, individuals with a history of diabetes, heart failure, or other serious heart conditions cannot participate. Throughout the study, participants will have regular check-ups to monitor their health and any changes in heart function. If you or someone you know meets these criteria and is interested in contributing to this important research, please consider reaching out for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Meeting all the following criteria:
• • 1. Aged 40 and above; less than 75 years.
• • 2. Hypertensive patients currently taking at least one antihypertensive medication as recommended by guidelines, and blood pressure is within the target range (\<140/90 mmHg).
• • 3. The left atrial volume index measured by transthoracic echocardiography exceeds 34 mL/m², or the ratio of the average E/e' \>9 and left atrial volume index \>= 29 mL/m² measured by transthoracic echocardiography.
• • 4. Signing an informed consent form.
• Exclusion Criteria:
• * • Exclusion criteria include any of the following conditions:
• • 1. History of diabetes.
• • 2. History of heart failure.
• • 3. History of coronary artery disease.
• • 4. Left ventricular systolic dysfunction, defined as LVEF \< 50%.
• • 5. Systolic blood pressure \< 100 mmHg.
• • 6. A history of arrhythmias such as atrial fibrillation, atrial flutter, frequent atrial premature contractions, and frequent ventricular premature contractions may impact the structural and functional aspects of the heart.
• • 7. Moderate and above valvular heart disease.
• • 8. Severe obstructive disease of the left ventricular outflow tract, including aortic valve stenosis.
• • 9. Visited within the past 1 month due to Genitourinary tract infection.
• • 10. Chronic kidney disease or estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73m².
• • 11. Alanine aminotransferase or aspartate aminotransferase levels \> 3 times the upper limit of normal.
• • 12. Contraindications to taking SGLT2 inhibitors.
• • 13. Currently taking SGLT2 inhibitors, SGLT-1/2 inhibitors, or other antihyperglycemic medications (including metformin, glucagon-like peptide-1 receptor agonists, etc.).
• • 14. Pregnancy or planning pregnant, or currently breastfeeding.
• • 15. Malignant tumors or other severe illnesses with a life expectancy of less than 3 years.
• • 16. History of alcohol abuse or substance abuse within the past year.
• • 17. Mental disorders or communication barriers, cognitive impairments, or other severe illnesses that may affect participation in the study.
• • 18. Participation in or currently participating in other clinical trials within the last 3 months.
• • 19. Known poor compliance with study follow-up or study drug.
• • 20. Any condition or contraindication that makes a person intolerant to magnetic resonance imaging (MRI) or contraindicates MRI examination, such as the presence of implanted intracranial aneurysm clips, cardiac pacemakers or defibrillators, insulin pumps, etc.