Investigating the effects of dapagliflozin on anemia in heart failure patients
A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)
This study is testing if the diabetes drug dapagliflozin can help improve anemia and reduce hospital visits for people with heart failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1990 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Xiangtan Central Hospital Academic / other |
| Locations | 1 site (Xiangtan, Hunan) |
| Trial ID | NCT04707261 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between changes in hemoglobin levels and the rates of heart failure readmissions and all-cause mortality in patients treated with dapagliflozin compared to a placebo. It is a double-blind, interventional trial that will follow participants over a period of one year, assessing the impact of dapagliflozin on anemia correction and heart failure outcomes. The study will include patients with heart failure who have elevated NT-proBNP or BNP levels and reduced ejection fraction, while adhering to standard therapy guidelines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 100 with heart failure symptoms and reduced ejection fraction.
Not a fit: Patients with severe renal disease or those who have previously been intolerant to SGLT2 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of anemia in heart failure patients, potentially reducing hospital readmissions and mortality rates.
How similar studies have performed: Previous studies have shown dapagliflozin to be effective in reducing heart failure events, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female between the ages of 18 and 100 years. 2. Elevated NT-proBNP or BNP levels on admission. 3. Ejection fraction of 50% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms. Exclusion Criteria: 1. Treatment with SGLT2-i during the past 3 months of admission,or previous intolerance of an SGLT2 inhibitor. 2. Severe (eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization. 3. Pregnant or breast feeding female patients.
Where this trial is running
Xiangtan, Hunan
- Xiangtan Central Hospital — Xiangtan, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Jianping Zeng, Ph.D.
- Email: 46595842@qq.com
- Phone: +86 15292271982
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.