Hypertension, Pre-Heart Failure
Conditions
Keywords
Pre-Heart Failure, Hypertension, Randomized controlled trial, Empagliflozin
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.
Detailed description
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.
Interventions
DRUGEmpagliflozin 10 MG
Each participant in the empagliflozin treatment group takes a daily dose of 10mg.
DRUGPlacebo
Each participant in the placebo group takes matching placebo.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* •
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of left atrial volume index | 6 months | Changes in Left Atrial Volume Index (LAVI, mL/m2) as measured by MRI from baseline to 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of cardiac structure and functional | 6 months | 1. Left ventricular functional indicators: Echocardiography/Magnetic Resonance Imaging measured Left Ventricular Ejection Fraction (LVEF, %), the ratio of early mitral inflow velocity to early diastolic mitral annular velocity (E/e', cm/s), and Global Longitudinal Strain (GLS, %). 2. Left ventricular structural indicators: Echocardiography/Magnetic Resonance Imaging measured Left Ventricular Mass Index (LVMI, g/m2). 3. Left atrial functional indicators: Echocardiography/Magnetic Resonance Imaging measured Left Atrial Ejection Fraction (LAEF, %) and echocardiography measured Left Atrial Volume Index (LAVI, mL/m2). |
| Biomarkers | 6 months | Biomarker concentrations were measured as follows: 1. NT-pro BNP in picograms per milliliter (pg/mL). 2. Cardiac Troponin I in nanograms per milliliter (ng/mL). 3. Cardiac Fibrosis Biomarkers, including Collagen type I alpha 1 (Col1A1) in nanograms per milliliter, Matrix Metalloproteinases (MMP-2, MMP-3, MMP-4) in picograms per milliliter (pg/mL) and soluble ST2 protein (sST-2) in nanograms per milliliter (ng/mL). 4. Inflammation Biomarkers, including High-sensitivity C-reactive protein (hs-CRP) in milligrams per liter (mg/L) and Interleukin-6 (IL-6), Interleukin-1β (IL-1β), and Galectin-3 (Gal-3) in picograms per milliliter (pg/mL). |
| Estimated Glomerular Filtration Rate (eGFR) | 6 months | Change of eGFR |
Countries
China
Contacts
CONTACTXin Zheng, MD,PhD
PRINCIPAL_INVESTIGATORXin Zheng, MD,PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed