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

StatusRecruiting
PhasePhase 4
Started2024-01-19
View on ClinicalTrials.gov ↗

Amendment history

2026-03-04
Study Status, Eligibility v3
Primary completion date2024-10-31→2026-12-31
Completion date2024-12-31→2026-12-31
Eligibility criteria+176 characters
Inclusion Criteria: • Meeting all the following criteria: Aged 4018 years and above; less than 75 years. Hypertensive patients currently taking at least one antihy [...] d blood pressure is within the target range (<140/90 mmHg). TheWithin left3 atrialmonths volumeprior indexto measuredscreening，result bymeet transthoracic echocardiography exceeds 34 mL/m², or the ratioany of the averagefollowing E/e' >9 and leftcriteria: Left atrial volume index >= 2934 mL/m² measured by transthoracicechocardiography; Average E/e' > 9 measured by echocardiography; NT-proBNP > 125 ng/ml. Signing an informed consent f [...] [...]
2024-04-21
Study Status, Eligibility v2
Eligibility criteria+57 characters
[...] ood pressure is within the target range (<140/90 mmHg). The ratio of E/e' >9 measured by transthoracic echocardiography. Leftleft atrial volume index measured by transthoracic echocardiography exceedingexceeds 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 Criteria: • Ex [...] rtic valve stenosis. Visited within the past 1 month due to GgenitourinaryGenitourinary tract infection. Chronic kidney disease or estimated Glomer [...]
2024-01-16
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-11-01→2024-01-19
Study sites0→2
Eligibility criteria+147 characters
Inclusion Criteria: • Meeting all the following criteria: Aged 40 and above; less than 75 years. Hypertensive patients currently taking at least one antihy [...] d blood pressure is within the target range (<140/90 mmHg). B-typeThe natriureticratio peptideof (BNP)E/e' levels>9 betweenmeasured 35-280by pg/mLtransthoracic or N- terminal pro-B-type natriuretic peptide (NT-pro BNP) levels between 125-1000 pg/mL in the past 6 monthsechocardiography. Left atrial volume index measured by transthoracic echocardiography exceeding 34 mL/m² in the past 6 months. Signing an informed consent form. Exclusion Crite [...] [...]
Secondary endpoints4 to 3 entries
Vascular Compliance
Study description-430 characters
AsHypertension ais criticalthe leading risk factor for heart failure, hypertension can induce left ventricular hypertrophy, decrease cardiac function, and ultimately lead to the development 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 failure (stage B), it's critical to explore the effect of additional cardioprotective medication in addition to well-controlled blood pressure. Sodium-glucose cotransporter-2 inhibitors (SGLT2engagliflozin) inhibitors have been confirmedshown to reducei [...] [...]
Study title-13 characters
The Effects and Mechanism of SGLT2 Inhibitors in Stage B of HeartPre-heart Failure Populations With Hypertension
2023-09-20
Original filing
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.
Trial Details
NCT Number NCT06055452
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Pre-Heart Failure, Hypertension
Enrollment 120 participants
Start Date 2024-01-19
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-05