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Cancelled by the investigator Effect of Henagliflozin on cardiac function and structure in HFpEF patients with combined type 2 diabetes mellitus

Effect of Henagliflozin on cardiac function and structure in HFpEF patients with combined type 2 diabetes mellitus: a single-center, prospective, observational cohort study

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096365
Enrollment
Unknown
Registered
2025-01-22
Start date
2025-01-22
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Type 2 diabetes combined with HFpEF

Interventions

Exposure group:Taking Henagliflozin
Non-exposure group:Do not take Henagliflozin

Sponsors

Department of Cardiovascular Medicine, Hubei Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years, =300 pg/ml (NT-pro BNP >=600 pg/ml for patients with atrial fibrillation); 3. Patients with confirmed chronic heart failure with preserved ejection fraction (LVEF>=50%); 4. Combined with type 2 diabetes mellitus, glycosylated hemoglobin (HbA1c) is between 7%-11%; 5. Cardiac Function Grading (NYHA) Class II-III; 6. Use of stable doses of guideline-recommended heart failure treatment drugs for at least 1 month prior to enrollment; 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of acute myocardial infarction, stroke or cardiac surgery within 6 months; 2. Severe valvular disease, pericardial disease or congenital heart disease; 3. Those who have been intolerant to other SGLT2 inhibitors in the past; 4. Use of SGLT2 inhibitors in the past 7 days; 5. Use of short-acting GLP-1RA in the past 7 days and long-acting GLP-1RA within 14 days; 6. Patients with active malignant tumors and unstable conditions, drug abuse or addiction; 7. In addition to the above, patients judged by the investigator to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Left ventricular end-diastolic volume (LVEDV);Left ventricular end-systolic volume (LVESV);

Secondary

MeasureTime frame
Left ventricular end-diastolic volume (LVEDV);Left ventricular end-systolic volume (LVESV);Left ventricular mass index (LVMI);

Countries

China

Contacts

Public ContactJingyi Zhang; Nianfang Luo

Department of Cardiovascular Medicine, Hubei Third People's Hospital

83351627@qq.com+86 153 0715 1800

Outcome results

None listed

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