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Sodium glucose transporter 2 (SGLT2) inhibition with empagliflozin improves peak oxygen uptake in heart failure with midrange ejection fraction patients

Sodium glucose transporter 2 (SGLT2) inhibition with empagliflozin improves peak oxygen uptake in heart failure with midrange ejection fraction patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046639
Enrollment
Unknown
Registered
2021-05-24
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure with midrange ejection fraction

Interventions

Experimental group:empagliflozin 10mg every day
control group:according to guidelines

Sponsors

Cardiology department of China-Japan friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years, gender is not limited; 2.Confirmed HFmrEF, according to the 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure, meets the following three criteria: symptoms of heart failure (NYHAII-IV) and/or signs,NTproBNP>=400pg/mL,40%<=LVEF<50%; 3.Signed Informed Consent.

Exclusion criteria

Exclusion criteria: 1.Known cardiomyopathy, pericardium disease, valvular disease; 2.The primary disease (coronary heart disease, hypertension, diabetes, etc.)is unstable ; 3.Hypotension or other conditions that can not tolerate the study medicine ; 4.Contraindications for cardiopulmonary exercise testing including but not limited to, left main stenosis, acute heart failure, moderate to severe valve stenosis, hypertrophy cardiomyopathy, outflow tract stenosis, severe arrhythmia, acute pulmonary embolism, aortic dissection, acute myocarditis, acute pericarditis, infection affecting motor function, thyroid dysfunction, electrolyte disorder, uncontrolled hypertension, mental illness, etc; 5.Other conditions that are not suitable for clinical study include but are not limited to severe abnormal liver and kidney function (ALT or AST greater than three times the upper limit, estimated glomerular filtration rate less than or equal to 45 mL /min), pregnancy or breastfeeding, and life expectancy of malignant tumor less than 2 years.

Design outcomes

Primary

MeasureTime frame
Peak oxygen uptake;

Secondary

MeasureTime frame
N terminal pro B type natriuretic peptide;6 minute walk test;

Countries

China

Contacts

Public ContactSun Yihong

China-Japan friendship Hospital

yihongsun72@163.com+86 13811224720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026