Status:
RECRUITING
Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Pre-Heart Failure
Hypertension
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief 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 ...
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 fai...
Eligibility Criteria
Inclusion
- • Meeting all the following criteria:
- Aged 40 and above; less than 75 years.
- Hypertensive patients currently taking at least one antihypertensive medication as recommended by guidelines, and blood pressure is within the target range (\<140/90 mmHg).
- The left atrial volume index measured by transthoracic echocardiography exceeds 34 mL/m², or the ratio of the average E/e' \>9 and left atrial volume index \>= 29 mL/m² measured by transthoracic echocardiography.
- Signing an informed consent form.
Exclusion
- • Exclusion criteria include any of the following conditions:
- History of diabetes.
- History of heart failure.
- History of coronary artery disease.
- 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.
- 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.
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06055452
Start Date
January 19 2024
End Date
December 31 2024
Last Update
April 23 2024
Active Locations (2)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
2
Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen
Shenzhen, Guangdong, China, 518038