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

Sponsor
China National Center for Cardiovascular Diseases
Study ID
NCT06055452
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Each participant in the empagliflozin treatment group takes a daily dose of 10mg.
  • Placebo — DRUG
    Each participant in the placebo group takes matching placebo.

Study Details

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.

Key Dates

Start date
Jan 19, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Empagliflozin
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change of left atrial volume index [ Time Frame: 6 months ]

Central Contacts

Related Studies