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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.
Hypertension is the leading risk factor of heart failure with preserved heart failure. The overall control rate is about 16% in China. Given the large amounts of hypertensive patients at pre-heart failure (stage B), it's critical to explore the effect of additional cardioprotective medication in addition to well-controlled blood pressure. Sodium-glucose cotransporter-2 inhibitors (engagliflozin) have been shown to improve cardiac function or prognosis in patients with diabetes or heart failure. However, whether it has a cardioprotective effect on hypertensive patients with pre-heart failure and without diabetes remains unknown. We will conduct a multicenter, randomized, placebo-controlled trial in pre-heat failure patients with hypertension and without diabetes. We will enroll 120 eligible patients randomized to receive a 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. The secondary endpoints include echocardiography or magnetic resonance imaging to measure structural and functional parameters, blood pressure, glucose, and blood biomarkers of inflammation and fibrosis. We sought to comprehensively evaluate the effect of empagliflozin on the structure and function and explore the underlying mechanisms to provide insights and evidence for the prevention of heart failure in hypertensive patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | Each participant in the empagliflozin treatment group takes a daily dose of 10mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of left atrial volume index | Changes in Left Atrial Volume Index (LAVI, mL/m2) as measured by MRI from baseline to 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of cardiac structure and functional |
|
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Inclusion Criteria:
• 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:
Signing an informed consent form.
Exclusion Criteria:
• Exclusion criteria include any of the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Zheng, MD,PhD | Contact | +86 13681077247 | zhengxin@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Zheng, MD,PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Placebo | Drug | Each participant in the placebo group takes matching placebo. |
|
| 6 months |
| Biomarkers | Biomarker concentrations were measured as follows:
| 6 months |
| Estimated Glomerular Filtration Rate (eGFR) | Change of eGFR | 6 months |
| Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen | Recruiting | Shenzhen | Guangdong | 518038 | China |
|