Dapa Acute Heart Failure Study

February 15, 2024 updated by: Professor Bryan Ping Yen YAN, Chinese University of Hong Kong

The Effect of Early Inpatient Initiation of Dapagliflozin on the Health-related Quality of Life of Patients With Heart Failure With All Range of Ejection Fraction: a Local Registry

Heart failure (HF) is one of the most important reasons for hospital admission and is associated with high mortality and morbidity. After discharge, up to 40% of patients are readmitted within 6 months and 1-year post-discharge mortality is high. The cost burden of treating patients with HF is high and ~80% of healthcare costs are related to hospital admissions.

Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF.

This is an investigator-initiated, prospective, single-centre, registry that evaluates the change in HRQL as measured by the KCCQ-TSS after the initiation of Dapagliflozin.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) is one of the most important reasons for hospital admission and is associated with high mortality and morbidity and poor quality of life (1). After discharge, up to 40% of patients are readmitted within 6 months and 1-year post-discharge mortality is high (2-4). The cost burden of treating patients with HF is high and ~80% of healthcare costs are related to hospital admissions (5).

Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF (6) However, guidelines do not specify the sequence and the timing of which therapy to be commenced. In particular, dapagliflozin has been shown in randomized controlled trials to reduce the combined risk of cardiovascular death or HF hospitalization and improve quality of life in HF patients with both reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively, regardless of the presence or absence of diabetes in the DAPA-HF and PRESERVED-HF trials (7, 8).

HF patient usually has poor QoL, and health-related quality of life (HRQL) measure has been shown to be associated with all cause death and HF hospitalization in a multinational study (9). There exist a geographical and ethnical variation in patients HRQL and clinical outcomes amongst various countries (9). The Kansas City Cardiomyopathy Questionnaire-total symptom scores (KCCQ-TSS) is a simple, widely available, and inexpensive tool that characterizes a patient's HF-related health status. Showing that it can be used as a marker to predict major clinical outcomes in a wide spectrum of patients with HF across the world would confirm its usefulness in research as well as in clinical practice.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong, 999077
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This is based on the primary objective and calculation

Description

Inclusion Criteria:

  1. Subject age >18 hospitalized for primary diagnosis of acute HF

  2. Dyspnoea (exertional or at rest) and 1 of the following signs:

    • Congestion on chest X-ray
    • Rales on chest auscultation
    • Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale)
    • Elevated jugular venous pressure
  3. NT-proBNP ≥300 ng/L (If ongoing atrial fibrillation/flutter at recruitment, NT-pro BNP must be ≥ 600 pg/mL.4. 5).

Exclusion Criteria:

  1. Cardiogenic shock
  2. Current hospitalization for acute HF primarily triggered by pulmonary embolism or cerebrovascular accident.
  3. Interventions in the past 30 days prior or planned during the study: Major cardiac surgery, or TAVI, or PCI, or MitraClip
  4. Current or expected heart transplant, LVAD, on IABP or other forms of mechanical support.
  5. Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study.
  6. eGFR <20 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis
  7. Type 1 diabetes mellitus
  8. History of ketoacidosis, including diabetic ketoacidosis
  9. Prior treatment with SGLT2 inhibitors in 90 days prior to current admission.
  10. Documented severe allergy or intolerance to SGLT2 inhibitors.
  11. Pregnant subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in KCCQ-TSS
Time Frame: Change from baseline in KCCQ-TSS after 90 days of treatment.
Change from baseline in KCCQ-TSS after 90 days of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in log-transformed NT-proBNP level
Time Frame: Change from baseline in log-transformed NT-proBNP level over 90 days of treatment
Change from baseline in log-transformed NT-proBNP level over 90 days of treatment
Change in NYHA class
Time Frame: Change in NYHA class over 90 days of treatment
Change in NYHA class over 90 days of treatment
Days alive and out of hospital from study drug initiation
Time Frame: 90 days
90 days
Days alive and out of hospital from study drug initiation
Time Frame: Days alive and out of hospital from study drug initiation until 90 days after randomization
Days alive and out of hospital from study drug initiation until 90 days after randomization
Time to first occurrence of cardiovascular death or heart Dapa AHF study Ver. 1.4 dated 7Oct2022 2 failure event
Time Frame: 90 days
90 days
Occurrence of HHF
Time Frame: Occurrence of HHF until 90 days after initial hospital discharge
Occurrence of HHF until 90 days after initial hospital discharge
Occurrence of Sustained eGFR reduction of ≥40% eGFR, or - Sustained eGFR <15mL/min/1.73m2 for patients with baseline eGFR ≥30 mL/min/1.73m2 - Sustained eGFR <10mL/min/1.73m2 for patients with baseline eGFR <30 mL/min/1.73m2.
Time Frame: Occurrence of Sustained eGFR until 90 days after initial hospital discharge
Occurrence of Sustained eGFR until 90 days after initial hospital discharge
Change from baseline in 6MWD
Time Frame: Change from baseline in 6MWD at 90 days
Change from baseline in 6MWD at 90 days
Cost effectiveness of early initiation of dapagliflozin for heart failure events avoided
Time Frame: 90 days
90 days
Clinical benefit
Time Frame: 90 days
a composite of all-cause mortality, number of heart failure events (including hospitalization for HFs, urgent heart failure visits and unplanned outpatient visits)
90 days
quality-of-life years (QALY) gained of dapagliflozin for heart failure events avoided
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2023

Primary Completion (Estimated)

September 9, 2025

Study Completion (Estimated)

December 9, 2025

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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