Could a diabetes drug stop heart failure before it starts?
NCT ID NCT06055452
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily pill called engagliflozin (a type of SGLT2 inhibitor) can improve heart function in people who have high blood pressure and early signs of heart failure but do not have diabetes. About 120 adults will receive either the drug or a placebo for 6 months. The main goal is to see if the drug reduces the size of the heart's left upper chamber, which is a marker of heart strain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * • Exclusion criteria include any of the following conditions: 1. History of diabetes. 2. History of heart failure. 3. History of myocardial infarction, acute coronary syndrome within the past 6 months, or planned coronary revascularization within the next 6 months 4. Left ventricular systolic dysfunction, defined as LVEF \< 50%. 5. Systolic blood pressure \< 100 mmHg. 6. 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. 7. Moderate and above valvular heart disease. 8. Severe obstructive disease of the left ventricular outflow tract, including aortic valve stenosis. 9. Confirmed diagnosis of cardiomyopathy and infiltrative myocardial diseases. 10. Visited within the past 1 month due to Genitourinary tract infection. 11. Chronic kidney disease or estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73m². 12. Alanine aminotransferase or aspartate aminotransferase levels \> 3 times the upper limit of normal. 13. Contraindications to taking SGLT2 inhibitors. 14. Currently taking SGLT2 inhibitors, SGLT-1/2 inhibitors, or other antihyperglycemic medications (including metformin, glucagon-like peptide-1 receptor agonists, etc.). 15. Pregnancy or planning pregnant, or currently breastfeeding. 16. Malignant tumors or other severe illnesses with a life expectancy of less than 3 years. 17. History of alcohol abuse or substance abuse within the past year. 18. Mental disorders or communication barriers, cognitive impairments, or other severe illnesses that may affect participation in the study. 19. Participation in or currently participating in other clinical trials within the last 3 months. 20. Known poor compliance with study follow-up or study drug. 21. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen
RECRUITINGShenzhen, Guangdong, 518038, China
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Fuwai Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100037, China
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