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Effect of SGLT-2 inhibitor, dapagliflozin, on left ventricular remodellilng in patients with type 2 diabetes and HFrEF

Effect of SGLT-2 inhibitor, dapagliflozin, on left ventricular remodellilng in patients with type 2 diabetes and HFrEF

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072707
Enrollment
Unknown
Registered
2023-06-21
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Heart Failure

Interventions

dapagliflozin group:Patients received dapaglifozin 10 mg once daily for 1year
Placebo group:Patients received placebo once daily for 1 year

Sponsors

Jiangxi Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: be at least 18 years old, have a confirmed diagnosis of type 2 diabetes, have an ejection fraction of 40% or lower, and exhibit New York Heart Association (NYHA) class II, III, or IV symptoms. Additionally, Patients were mandated to possess a plasma concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) equal to or exceeding 600 pg per milliliter. If patients had atrial fibrillation or atrial flutter upon baseline electrocardiography, their NT-proBNP level needed to be at least 900 pg per milliliter.

Exclusion criteria

Exclusion criteria: recent use of or intolerable side effects related to an SGLT2 inhibitor, presence of type 1 diabetes mellitus, hypotension symptoms or a systolic blood pressure below 90 mm Hg, and an estimated glomerular filtration rate (eGFR) lower than 30 ml per minute per 1.73 m2 of body surface area (or experiencing rapid decline in renal function).

Design outcomes

Primary

MeasureTime frame
left ventricular ejection fraction;left ventricular end-diastolic volume;left ventricular end-systolic volume;left ventricular end-diastolic diameter;left ventricular end-systolic diameter;

Secondary

MeasureTime frame
velocity time integral;Cardiac index output;Systolic pulmonary pressure;

Countries

China

Contacts

Public ContactLan Cheng

Jiangxi Provincial People's Hospital

471907791@qq.com+86 189 9560 0983

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026