Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)

Xiangtan Central Hospital

Status and phase: Enrolling; Phase 4

Conditions: Anemia; Heart Failure

Treatments: Drug: Placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT04707261

2020/12/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,990 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,990 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT

Treatment:

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Description:

Standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT

Treatment:

Drug: Placebo