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Pre-Heart FailurePhase 4NCT06055452

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

A Phase 4 study testing Empagliflozin 10 MG in people with Pre-Heart Failure and Hypertension, run by China National Center for Cardiovascular Diseases at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pre-Heart Failure, Hypertension
What is being tested?
Empagliflozin 10 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesChina
Study dates
19 Jan 2024to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xin Zheng, MD,PhD contact

+86 13681077247

zhengxin@fuwai.com

China2 sites, 2 recruiting

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

    Xin Zheng, MD,PhD, +86 13681077247, zhengxin@fuwai.com

    Recruiting

  • Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen

    Shenzhen, Guangdong, 518038

    Wenyu Guo, MD,PhD, 15813833652, 405514738@qq.com

    Recruiting

Other trials in China

About this study

Official title: Effects and Mechanism of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension

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.

Read the 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.

Being tested
Empagliflozin 10 MG, Placebo
Keywords
Pre-Heart Failure, Hypertension, Randomized controlled trial, Empagliflozin
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10 MGDrug

    Also called Jardiance®

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

  • PlaceboDrug

    Each participant in the placebo group takes matching placebo.

Study groups in NCT06055452
Study groupRoleWhat they receive
EmpagliflozinExperimentalNot described
Receives: Drug: Empagliflozin 10 MG
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (3)

  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).

    Measured: 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).

    Measured: 6 months

  3. Estimated Glomerular Filtration Rate (eGFR)

    Change of eGFR

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start19 Jan 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055452
Sponsor's protocol ID
2023-GSP-GG-18
Status last verified
Mar 2026
First submitted
14 Sep 2023
Last updated
5 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin 10 MG in people with Pre-Heart Failure and Hypertension, run by China National Center for Cardiovascular Diseases at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xin Zheng, MD,PhD (+86 13681077247, zhengxin@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of left atrial volume index (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06055452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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