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

Last updated: June 27, 2024
Sponsor: Xiangtan Central Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Congestive Heart Failure

Heart Failure

Chest Pain

Treatment

Placebo

Dapagliflozin

Clinical Study ID

NCT04707261
2020/12/01
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Treatment with SGLT2-i during the past 3 months of admission,or previous intoleranceof an SGLT2 inhibitor.

  2. Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renaldisease at the time of randomization.

  3. Pregnant or breast feeding female patients.

Study Design

Total Participants: 1990
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
August 06, 2021
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • Xiangtan Central Hospital

    Xiangtan, Hunan 411100
    China

    Active - Recruiting

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