NCT06055452 Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
| NCT ID | NCT06055452 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Pre-Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-01-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: • Meeting all the following criteria: 1. Aged 18 years and above. 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. Within 3 months prior to screening，result meet any of the following criteria: 1. Left atrial volume index \> 34 mL/m² measured by echocardiography; 2. Average E/e' \> 9 measured by echocardiography; 3. NT-proBNP \> 125 ng/ml. 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 myocardial infarction, acute coronary syndrome within the past 6 months, or planned coronary revascularization within the next 6 months 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. Confirmed diagnosis of cardiomyopathy and infiltrative myocardial diseases. 10. Visited within the past 1 month due to Genitourinary tract infection. 11. Chronic kidney disease or estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73m². 12. Alanine aminotransferase or aspartate aminotransferase levels \> 3 times the upper limit of normal. 13. Contraindications to taking SGLT2 inhibitors. 14. Currently taking SGLT2 inhibitors, SGLT-1/2 inhibitors, or other antihyperglycemic medications (including metformin, glucagon-like peptide-1 receptor agonists, etc.). 15. Pregnancy or planning pregnant, or currently breastfeeding. 16. Malignant tumors or other severe illnesses with a life expectancy of less than 3 years. 17. History of alcohol abuse or substance abuse within the past year. 18. Mental disorders or communication barriers, cognitive impairments, or other severe illnesses that may affect participation in the study. 19. Participation in or currently participating in other clinical trials within the last 3 months. 20. Known poor compliance with study follow-up or study drug. 21. 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.
Contact & Investigator
Xin Zheng, MD,PhD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT06055452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pre-Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06055452 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06055452 currently recruiting?
Yes, NCT06055452 is actively recruiting participants. Contact the research team at zhengxin@fuwai.com for enrollment information.
Where is the NCT06055452 trial being conducted?
This trial is being conducted at Beijing, China, Shenzhen, China.
Who is sponsoring the NCT06055452 clinical trial?
NCT06055452 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Xin Zheng, MD,PhD at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 120 participants.
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