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

NCT06055452 | Recruiting Phase 4

• 1 other identifier: 2023-GSP-GG-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Pre-Heart Failure; Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of left atrial volume index

  Changes in Left Atrial Volume Index (LAVI, mL/m2) as measured by MRI from baseline to 6 months.

  6 months

Secondary Outcomes (3)

• Change of cardiac structure and functional

  6 months

• Biomarkers

  6 months

• Estimated Glomerular Filtration Rate (eGFR)

  6 months

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

Each participant in the empagliflozin treatment group takes a daily dose of 10mg.

Also known as: Jardiance®

Empagliflozin

Placebo DRUG

Each participant in the placebo group takes matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (2)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen

Shenzhen, Guangdong, 518038, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xin Zheng, MD,PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Zheng, MD,PhD

CONTACT

+86 13681077247; zhengxin@fuwai.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 26, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)