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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Pre-Heart Failure, Hypertension

In brief

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.

Key facts

Study ID

NCT06055452

Run by

China National Center for Cardiovascular Diseases

People needed

120

Starts

2024-01-19

Expected to finish

2026-12-31

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meeting all the following criteria:
• Aged 18 years and above.
• Hypertensive patients currently taking at least one antihypertensive medication as recommended by guidelines, and blood pressure is within the target range (<140/90 mmHg).
• Within 3 months prior to screening，result meet any of the following criteria:
• Left atrial volume index > 34 mL/m² measured by echocardiography;
• Average E/e' > 9 measured by echocardiography;
• NT-proBNP > 125 ng/ml.
• Signing an informed consent form.

You may not qualify if…

• • Exclusion criteria include any of the following conditions:
• History of diabetes.
• History of heart failure.
• History of myocardial infarction, acute coronary syndrome within the past 6 months, or planned coronary revascularization within the next 6 months
• Left ventricular systolic dysfunction, defined as LVEF < 50%.
• Systolic blood pressure < 100 mmHg.
• 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.
• Moderate and above valvular heart disease.
• Severe obstructive disease of the left ventricular outflow tract, including aortic valve stenosis.
• Confirmed diagnosis of cardiomyopathy and infiltrative myocardial diseases.
• Visited within the past 1 month due to Genitourinary tract infection.
• Chronic kidney disease or estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73m².
• Alanine aminotransferase or aspartate aminotransferase levels > 3 times the upper limit of normal.
• Contraindications to taking SGLT2 inhibitors.
• Currently taking SGLT2 inhibitors, SGLT-1/2 inhibitors, or other antihyperglycemic medications (including metformin, glucagon-like peptide-1 receptor agonists, etc.).
• Pregnancy or planning pregnant, or currently breastfeeding.
• Malignant tumors or other severe illnesses with a life expectancy of less than 3 years.
• History of alcohol abuse or substance abuse within the past year.
• Mental disorders or communication barriers, cognitive impairments, or other severe illnesses that may affect participation in the study.
• Participation in or currently participating in other clinical trials within the last 3 months.
• Known poor compliance with study follow-up or study drug.
• 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.

Where it is running

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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