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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this multicenter, randomized, placebo-controlled trial in pre-heat failure patients with hypertension and without diabetes, we will enroll 120 eligible patients to randomized to receive placebo or engagliflozin (10mg/d) for follow them for 6 months. The primary endpoint is the left atrial volume index, which reflects left ventricular diastolic function. We sought to comprehensively evaluate the effect of engagliflozin on the structure and function and explore its underlying mechanisms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases
• Treatments: Empagliflozin

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.