Evaluating Dapagliflozin in Patients with Acute Heart Failure

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

This study is testing whether the medication dapagliflozin can help improve the quality of life for adults hospitalized with acute heart failure.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Shatin)
• Trial ID: NCT05759000 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients hospitalized for acute heart failure (HF) and aims to assess the impact of dapagliflozin on health-related quality of life (HRQL) as measured by the Kansas City Cardiomyopathy Questionnaire-total symptom scores (KCCQ-TSS). It will include adults over 18 years old who exhibit symptoms of dyspnea and specific clinical signs of HF. The study will exclude patients with severe complications or recent major cardiac interventions. By tracking changes in HRQL after initiating dapagliflozin, the study seeks to provide insights into the effectiveness of this treatment in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are hospitalized for acute heart failure with specific symptoms and clinical signs.

Not a fit: Patients experiencing cardiogenic shock or those with severe uncorrected cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved quality of life and reduced hospital readmissions for patients with acute heart failure.

How similar studies have performed: Previous studies have shown that SGLT2 inhibitors like dapagliflozin can improve outcomes in heart failure patients, indicating a promising approach.

Eligibility criteria

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

Where this trial is running

Shatin

• The Chinese University of Hong Kong — Shatin, Hong Kong (Recruiting)

Conditions Heart Failure; Dapagliflozin; acute heart failure