Actively Recruiting
Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
Led by China National Center for Cardiovascular Diseases · Updated on 2026-03-05
120
Participants Needed
2
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and above.
- Diagnosed with hypertension and currently taking at least one antihypertensive medication with blood pressure below 140/90 mmHg.
- Within 3 months before screening, meeting any of the following: left atrial volume index > 34 mL/m² by echocardiography, average E/e' > 9 by echocardiography, or NT-proBNP > 125 ng/ml.
- Signed informed consent form.
You will not qualify if you...
- History of diabetes.
- History of heart failure.
- History of myocardial infarction or acute coronary syndrome within the past 6 months, or planned coronary revascularization within the next 6 months.
- Left ventricular ejection fraction below 50%.
- Systolic blood pressure below 100 mmHg.
- History of arrhythmias like atrial fibrillation, flutter, or frequent premature contractions.
- Moderate or severe valvular heart disease.
- Severe obstructive disease of the left ventricular outflow tract such as aortic valve stenosis.
- Diagnosis of cardiomyopathy or infiltrative myocardial diseases.
- Genitourinary tract infection within the past 1 month.
- Chronic kidney disease or estimated glomerular filtration rate below 45 ml/min/1.73m².
- Alanine aminotransferase or aspartate aminotransferase levels more than three times the upper limit of normal.
- Contraindications to taking SGLT2 inhibitors.
- Current use of SGLT2 inhibitors, SGLT-1/2 inhibitors, or other antihyperglycemic medications.
- Pregnancy, planning pregnancy, or breastfeeding.
- Malignant tumors or severe illnesses with life expectancy under 3 years.
- History of alcohol or substance abuse within the past year.
- Mental disorders, communication barriers, cognitive impairments, or severe illnesses affecting study participation.
- Participation in other clinical trials within the last 3 months.
- Known poor compliance with follow-up or study medication.
- Conditions contraindicating MRI, including implanted aneurysm clips, pacemakers, defibrillators, or insulin pumps.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
2
Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen
Shenzhen, Guangdong, China, 518038
Actively Recruiting
Research Team
X
Xin Zheng, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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