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

Sponsor
Xiangtan Central Hospital
Study ID
NCT04707261
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Participants will receive dapagliflozin 10 mg once daily
  • Placebo — DRUG
    Participants will receive placebo 10 mg once daily

Study Details

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.

Key Dates

Start date
Aug 6, 2021
Status verified
Jun 2024
Primary completion
May 5, 2025
Completion
Jan 1, 2026

Study Design

Enrollment
1,990 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Composite number of hospital admissions for Heart Failure (HF) and all-cause death [ Time Frame: 1 year ]

Central Contacts

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