Clinical trial NCT05759000: Dapa Acute Heart Failure Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Dapagliflozin
acute heart failure
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is based on the primary objective and calculation

Brief summary: 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.

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.

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

Primary outcomes:
measure: Change from baseline in KCCQ-TSS
timeFrame: Change from baseline in KCCQ-TSS after 90 days of treatment.
Secondary outcomes:
measure: Change from baseline in log-transformed NT-proBNP level
timeFrame: Change from baseline in log-transformed NT-proBNP level over 90 days of treatment
measure: Change in NYHA class
timeFrame: Change in NYHA class over 90 days of treatment
measure: Days alive and out of hospital from study drug initiation
timeFrame: 90 days
measure: Days alive and out of hospital from study drug initiation
timeFrame: Days alive and out of hospital from study drug initiation until 90 days after randomization
measure: Time to first occurrence of cardiovascular death or heart Dapa AHF study Ver. 1.4 dated 7Oct2022 2 failure event
timeFrame: 90 days
measure: Occurrence of HHF
timeFrame: Occurrence of HHF until 90 days after initial hospital discharge
measure: 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.
timeFrame: Occurrence of Sustained eGFR until 90 days after initial hospital discharge
measure: Change from baseline in 6MWD
timeFrame: Change from baseline in 6MWD at 90 days
measure: Cost effectiveness of early initiation of dapagliflozin for heart failure events avoided
timeFrame: 90 days
measure: Clinical benefit
timeFrame: 90 days
measure: quality-of-life years (QALY) gained of dapagliflozin for heart failure events avoided
timeFrame: 90 days
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
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