Finerenone and Empagliflozin Combination in Obesity With Hypertension: A 12-Week Prospective, Parallel-design, Double-blind, Randomized, Placebo-controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorHeart Health Research Center

About this trial

The EFFORT Study (Empagliflozin and Finerenone Combination in Obesity with Hypertension) is a 12-week, randomized, double-blind, placebo-controlled trial that aims to test whether combining empagliflozin (10 mg/day) with finerenone (10 mg/day, up-titrated to 20 mg after 4 weeks) can significantly lower office systolic blood pressure in adults with obesity and stage 1 hypertension (systolic BP 140-160 mmHg) who are on up to two stable antihypertensives. The study will enroll 260 participants from community settings. Beyond blood pressure, the trial will also assess effects on diastolic pressure, cumulative BP exposure, urinary albumin-to-creatinine ratio, inflammation (hs-CRP), fasting glucose, body weight, and quality of life. Safety monitoring focuses on hyperkalemia, acute kidney injury, hypotension, and hypoglycemia. If positive, this research may offer a new, mechanism-based therapeutic strategy for the growing population with cardiometabolic risk, potentially providing better cardiovascular and kidney protection than conventional approaches.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Empagliflozin and Finerenone
  • Placebo for Empagliflozin and Finerenone

Treatment groups

260 Participants
are divided into 2 treatment groups

Locations

2
Beijing Anzhen Hospital, Capital Medical University BeijingBeijing Municipality, China
Ruyang County People's Hospital Luoyang China

Sponsors and collaborators

Heart Health Research Center

Lead sponsor