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Randomized Crossover Trial on the Effect of Henagliflozin on Heart Stress in Patients with Stage B Heart Failure

Randomized Crossover Trial on the Effect of Henagliflozin on Heart Stress in Patients with Stage B Heart Failure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108869
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-16
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Pre-heart failrue

Interventions

Henagliflozin group:Participants are randomly assigned into Henagliflozin group (10mg/qd) for 24 weeks
Control group:Participants are randomly assigned into control group for 24 weeks

Sponsors

Guangdong Provincial Yingde People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years with a prior diagnosis of hypertension, diabetes, coronary artery disease, chronic kidney disease, microalbuminuria or macroalbuminuria, obesity, or other risk factors for heart failure; 2. Plasma NT-proBNP levels meeting the age-specific threshold for heart stress: >= 75 pg/mL for individuals = 150 pg/mL for those aged 50–74, and >= 300 pg/mL for those >= 75 years old; 3. No clinical signs or symptoms of heart failure; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with Stage C heart failure (presence of typical symptoms or signs); 2. eGFR < 30 mL/min/1.73m^2 or requiring dialysis; 3. Recent (within the past 3 months) acute myocardial infarction, stroke, or unstable angina; 4. Currently using other SGLT2 inhibitors or GLP-1 receptor agonists; 5. Presence of severe liver dysfunction, active infection, or malignancy; 6. History of diabetic ketoacidosis, type 1 diabetes mellitus, or gestational diabetes; 7. Pregnant or breastfeeding women, or those planning pregnancy; 8. Moderate to severe mitral or aortic valve stenosis or regurgitation.

Design outcomes

Primary

MeasureTime frame
N-terminal pro-B-type netriuretic peptide;

Secondary

MeasureTime frame
Cardiac structure and function on echocardiography;

Countries

China

Contacts

Public ContactAnping Cai

Guangdong Provincial Yingde People's Hospital

acai0120@hotmail.com+86 763 222 2733

Outcome results

None listed

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