Effects of a medication on heart health in patients with high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, placebo-controlled trial aims to evaluate the effects of empagliflozin on pre-heart failure patients with hypertension who do not have diabetes. A total of 120 eligible participants will be enrolled and randomly assigned to receive either empagliflozin (10mg daily) or a placebo for a duration of six months. The primary endpoint is the left atrial volume index, which indicates left ventricular diastolic function, while secondary endpoints will include various structural and functional cardiac parameters, blood pressure, and biomarkers of inflammation and fibrosis. The study seeks to provide insights into the cardioprotective effects of empagliflozin in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Principal investigator: Xin Zheng, MD,PhD — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Xin Zheng, MD,PhD
• Email: zhengxin@fuwai.com
• Phone: +86 13681077247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.