Henagliflozin's effect on heart function in diabetes patients with heart failure
Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure: a Multicenter, Prospective, Pragmatic Randomized Controlled Trial
This study is testing if a daily dose of Henagliflozin can improve heart function in people with type 2 diabetes and heart failure compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1932 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05742230 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Henagliflozin, a medication administered at a daily dose of 10 mg, compared to a blank control in patients with type 2 diabetes and symptomatic heart failure. The primary outcome will be measured using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score to assess improvements in heart function. Participants must be clinically stable and meet specific criteria related to heart failure severity and diabetes management. The study will involve monitoring participants' responses to the treatment over a defined period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 2 diabetes and symptomatic heart failure who meet specific clinical criteria.
Not a fit: Patients who are pregnant, lactating, or have severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and quality of life for patients with type 2 diabetes and heart failure.
How similar studies have performed: Other studies have shown promising results with similar medications in improving heart function in diabetic patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with T2DM aged ≥18 years * 6.5%≤HbA1c≤11% * Clinically stable symptomatic heart failure (a) For HFrEF: (a) Ejection fraction (EF) less than or equal to (\<=) 40% and (b) diagnosis of chronic heart failure within the past 18 months (B) For HFpEF: (a) EF greater than (\>) 40%; (b) Diagnosis of chronic heart failure within the past 18 months * Symptoms of heart failure at visit 1 (NYHA II-IV) * KCCQ-OSS score \< 80 at screening visit * NT-proBNP \> 125 pg/mL, or NT proBNP \> 365 pg/mL in atrial fibrillation patients; Or BNP \> 35 pg/mL, or BNP \> 105 pg/mL in atrial fibrillation patients at screening visit * Subject must have received (and be receiving) at least one stable optimal dose of guidelines recommended HF drugs (e.g., ACEi, ARB, ARNI, beta blockers, oral diuretics, MRA) prior to visit 1 * eGFR≥30 ml/min/1.73m2 at screening visit (CKD-EPI formula) * Signed and dated written ICF Exclusion Criteria: * Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception * Known allergy to Henagliflozin * Hospitalization for acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 4 weeks before the screening visit * Acute decompensated heart failure or hospitalization for decompensated heart failure within 4 weeks * History of heart transplantation or ventricular assist device (VAD), or intention to heart transplantation or VAD * Perinatal or chemotherapy-induced cardiomyopathy within 12 months * Documented untreated ventricular arrhythmias with syncope within 3 months * Diagnosed respiratory diseases * Type I diabetes * T2DM with history of ketoacidosis (DKA) * Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening visit * Symptomatic hypotension and/or systolic blood pressure \<90 mmHg at visit 0 or visit 1, or hypovolemia * History of recurrent urinary and reproductive tract infections * Current use or prior use of a SGLT-2i or GLP-1RA within 3 months * Diagnosed malignant tumors * Further exclusion criteria apply
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jian'an Wang, MD — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
- Study coordinator: Jun Jiang, MD
- Email: drjayj@hotmail.com
- Phone: 13588706891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.