NCT04707261

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,990

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

3.7 years

First QC Date

December 31, 2020

Last Update Submit

June 27, 2024

Conditions

AnemiaHeart Failure

Keywords

Heart FailureAnemiaDapagliflozin

Outcome Measures

Primary Outcomes (1)

  • Composite number of hospital admissions for Heart Failure (HF) and all-cause death

    Total number of deaths and heart failure hospitalizations in one year

    1 year

Secondary Outcomes (3)

  • Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score

    Baselin, 3 months, 6 months, and 1 year

  • Change in 6-minute walk distance (6MWD)

    Baselin, 3 months, 6 months, and 1 year

  • Change in hemoglobin

    Baselin, 3 months, 6 months, and 1 year

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DapagliflozinDRUG

Participants will receive dapagliflozin 10 mg once daily

Also known as: FORXIGA
Dapagliflozin
PlaceboDRUG

Participants will receive placebo 10 mg once daily

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between the ages of 18 and 100 years.
  • Elevated NT-proBNP or BNP levels on admission.
  • Ejection fraction of 50% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms.

You may not qualify if:

  • Treatment with SGLT2-i during the past 3 months of admission,or previous intolerance of an SGLT2 inhibitor.
  • Severe (eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization.
  • Pregnant or breast feeding female patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangtan Central Hospital

Xiangtan, Hunan, 411100, China

RECRUITING

Related Publications (1)

  • Zeng J, Zhu Y, Zhao W, Wu M, Huang H, Huang H, Wu C, Zhou X, Zhou S, Wang C, Yin K, Xu F, Cai Z, Li X, Cheng H, Xie Y, Tan Z, Hu X, Liao D, Wang Y. Rationale and Design of the ADIDAS Study: Association Between Dapagliflozin-Induced Improvement and Anemia in Heart Failure Patients. Cardiovasc Drugs Ther. 2022 Jun;36(3):505-509. doi: 10.1007/s10557-021-07176-0. Epub 2021 Mar 29.

    PMID: 33779938DERIVED

MeSH Terms

Conditions

AnemiaHeart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Jianping Zeng, Ph.D.

    Xiangtan Central Hospital

    STUDY CHAIR

  • Shenghua Zhou, Ph.D.

    Second Xiangya Hospital of Central South University

    STUDY DIRECTOR

  • Chengming Wang, Ph.D.

    ZhuZhou Central Hospital

    STUDY DIRECTOR

  • Fanghua Xu, M.D.

    The First People's Hospital of Xiangtan City

    STUDY DIRECTOR

  • Zhiqiang Cai, M.D.

    Xiangtan People's Hospital

    STUDY DIRECTOR

  • Chonglun Zhou, M.D.

    Xiangxiang People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Jianping Zeng, Ph.D.

CONTACT

+86 1529227198246595842@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Xiangtan Centeral Hospital

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 13, 2021

Study Start

August 6, 2021

Primary Completion

May 5, 2025

Study Completion

January 1, 2026

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)