NCT06055452RecruitingPhase 4
Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
Effects and Mechanism of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 14 Sept 2023
- Start date
- 19 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT06055452
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 19 Jan 2024 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.