Anemia, Heart Failure
Conditions
Keywords
Heart Failure, Anemia, Dapagliflozin
Brief summary
The primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo.
Detailed description
Study Description Brief Summary: The primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo. Detailed Description: Heart failure is one of the most serious health concerns in the world, and it also remains the most common reason for hospitalization in older individuals. In patients with heart failure, anemia is associated with an increased risk of hospitalization and all-cause mortality. The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure (HF) events and cardiovascular death comparing to placebo in patients with reduced ejection fraction on top of standard of care. This is an investigator-initiated, interventional, prospective, double-blind study. The primary objective is to investigate whether anemia correction is one of the prerequisites and determinants related to the beneficial effects of dapagliflozin in patients with heart failure. Impact of dapagliflozin treatment on hemoglobin level, heart failure-related readmission and all-cause death will be observed in comparison with placebo in heart failure patients receiving guideline recommended standard therapy during the 3months, 6 months and 1 year follow up.
Interventions
DRUGDapagliflozin
Participants will receive dapagliflozin 10 mg once daily
DRUGPlacebo
Participants will receive placebo 10 mg once daily
Sponsors
Second Xiangya Hospital of Central South University
ZhuZhou Central Hospital
Xiangtan Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite number of hospital admissions for Heart Failure (HF) and all-cause death | 1 year | Total number of deaths and heart failure hospitalizations in one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score | Baselin, 3 months, 6 months, and 1 year | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Change in 6-minute walk distance (6MWD) | Baselin, 3 months, 6 months, and 1 year | This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. |
| Change in hemoglobin | Baselin, 3 months, 6 months, and 1 year | g/L |
Countries
China
Contacts
Primary ContactJianping Zeng, Ph.D.
Outcome results
None listed