Health TrialsbyHealthPanel

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

ConditionsPre-Heart FailureHypertension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Left atrial volume index > 34 mL/m² measured by echocardiography;

Average E/e' > 9 measured by echocardiography;

Disqualifiers

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%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 10 MG

    Drug

    Each participant in the empagliflozin treatment group takes a daily dose of 10mg.

  • Placebo

    Drug

    Each participant in the placebo group takes matching placebo.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: EmpagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of left atrial volume index

Changes in Left Atrial Volume Index (LAVI, mL/m2) as measured by MRI from baseline to 6 months.

Time frame
6 months

Secondary outcomes

1

Change of cardiac structure and functional

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).

Time frame
6 months
2

Biomarkers

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).

Time frame
6 months
3

Estimated Glomerular Filtration Rate (eGFR)

Change of eGFR

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Source ClinicalTrials.gov
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