Patients with HFr/mrEF hospitalized for decompensated HF with renal dysfunction. Heart Failure, HFrEF, HFmrEF, Renal Dysfunction, GDMT
Conditions
Interventions
In the protocolized GDMT recommendation group, treating physicians are given recommendations on GDMT management including BB, renin-angiotensin system inhibitors (RASi), MRA and SGLT2i. It supports th
Sponsors
Matsue Yuya
AstraZeneca K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of informed consent prior to any study specific procedures. >=20 years Hospitalized with a diagnosis of decompensated heart failure with all of the following characteristics at the time of admission: Dyspnoea at rest or induced by slight exertion At least two of the following findings: jugular venous distention, pulmonary rales, lower leg oedema, and pulmonary congestion on chest X-ray If the patient has a sinus rhythm at the time of admission, BNP>=100 pg/mL or NT-proBNP >=600 pg/mL; if the patient has atrial fibrillation at the time of admission, BNP>=200 pg/mL or NT-proBNP>=900 pg/mL Hemodynamically stable satisfying all the following criteria at the time of screening Between 24 and 96 hours after hospital admission The attending physician has determined that there has been no worsening of heart failure symptoms or physical findings for last >=24 hours, and that initiation of chronic heart failure GDMT is feasible SBP >=100 mmHg and HR >=50 /min Free from vasodilators (intravenous injection only), inotropes (intravenous injection only), vasopressor, renal replacement therapy, mechanical circulatory support, and ventilation As treatment for chronic heart failure, the patient is receiving at least one agent of either GDMT or an oral diuretic. Left Ventricular Ejection Fraction (LVEF) measured within 6 months from screening =1 GDMT class at the time of screening
Exclusion criteria
Exclusion criteria: Renal artery stenosis At high risk of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) Worsening HF mainly due to acute coronary syndrome, pulmonary embolism, stroke, orbradycardia requiring initiation of pacing Following intervention within 30 days prior to enrollment; cardiovascular surgery [coronary artery bypass grafting (CABG), valve, transcatheter aortic valve replacement (TAVR), percutaneous coronary intervention (PCI), transcatheter edge-to-edge repair (TEER)], implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy - pacemaker/Cardiac Resynchronization Therapy/defibrillator (CRT-P/D), and ventricular assist device (VAD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine superiority in GDMT score at the time of discharge Only in case that superiority can be shown, then To examine non-inferiority in days alive and out of hospital (DAOH) within 60 days of enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective1 To assess the impact of recommending protocolized GDMT optimization on achievement of target dosages of each GDMT including beta blockers (BB), ACE inhibitors (ACEi), Angiotensin receptor blockers (ARBs), SGLT2i, mineralocorticoid receptor antagonists (MRAs), and angiotensin receptor-neprilysin inhibitor (ARNI) in hospitalized patients with HFr/mrEF and renal dysfunction. Outcome measure (1) prescription at any dose; (2) attainment of 50% or more of the target dose; and (3) attainment of the target dose for each GDMT-BB, ACEi, ARB, SGLT2i, MRA, and ARNI at the time of discharge and at 60 days of enrollment Secondary objective2 To assess the impact of recommending protocolized GDMT optimization on quality of life, severity of HF, and congestive symptoms in hospitalized patients with HFr/mrEF and renal dysfunction. Outcome measure Changes in KCCQ-TSS, NYHA class, heart sound, body weight and edema from the time of enrollment to discharge and to 60 days of enrollment Secondary objective3 To assess the reasons why optimization according to protocolized GDMT recommendations cannot be achieved in hospitalized patients with HFr/mrEF and renal dysfunction. Outcome measure Reasons why optimization according to the recommendations cannot be achieved from the time of enrollment to discharge Secondary objective4 To assess the impact of recommending protocolized GDMT optimization on biomarkers in hospitalized patients with HFr/mrEF and renal dysfunction. Outcome measure Changes in eGFR, NT-proBNP/BNP, serum/urine Na, K, Cl, Cr, and BUN from the time of enrollment to discharge and to 60 days of enrollment Secondary objective5 To assess the impact of recommending protocolized GDMT optimization on adverse events in hospitalized patients with HFr/mrEF and renal dysfunction. Outcome measure Incidence of adverse events (e.g., hyperkalemia, symptomatic hypotension, and renal dysfunction, etc.) Secondary objective6 To assess the impact of recommending protocoli | — |
Contacts
Public ContactYuya Matsue
Juntendo University Hospital
Outcome results
None listed