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

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

This study is testing if a heart medication called empagliflozin can improve heart health in people with high blood pressure who are at risk for heart failure but don’t have diabetes.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06055452 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are hypertensive individuals aged 40 to 75 who are currently on antihypertensive medication and have specific echocardiographic findings.

Not a fit: Patients with a history of diabetes, heart failure, or coronary artery disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart health and prevention of heart failure in hypertensive patients.

How similar studies have performed: Previous studies have shown positive outcomes with SGLT2 inhibitors in diabetic and heart failure populations, but this specific application in hypertensive pre-heart failure patients is novel.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 1 other locations

• 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

Conditions Pre-Heart Failure; Hypertension; Randomized controlled trial; Empagliflozin