Date

2026-01-27

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

1. Provide electronic or written informed consent, either personally or through a legally authorized representative 2. Age >18 years or legal age of majority 3. Current hospitalization or recently discharged with the primary diagnosis of heart failure 4. Heart failure signs and symptoms at the time of hospital admission 5. Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) >500 pg/ mL or B-type natriuretic peptide (BNP) >125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP >1500 pg/mL or BNP >375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission. 6. Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization) Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide). 7. Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Next Version

1. Provide written informed consent 2. Age ?18 years or legal age of majority if >18 years in the participant’s country of residence. 3. Current hospitalization1 or recently discharged (during or within 30 days of discharge) with a primary diagnosis of acute HF. 4. Heart failure signs and symptoms at the time of hospital admission, including: a. Symptoms (at least one of the following): persistent dyspnea at rest or with minimal exertion worse than baseline or new or worsening orthopnea, and; b. Signs of fluid overload (at least one of the following): congestion on chest X ray, rales on chest auscultation, clinically relevant edema caused by HF (as judged by the investigator), elevated jugular venous pressure. 5. Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ?500 pg/mL or B-type natriuretic peptide (BNP) ?125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ?1500 pg/mL or BNP ?375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization, in the 72 hours prior to hospital admission, or during the 30 days post-discharge. (Note: for patients treated with an angiotensin receptor neprilysin inhibitor [ARNI] in the previous 4 weeks prior to randomization, NTproBNP values should be used where available.) 6. Fulfillment of the following stabilization criteria (if randomized during hospitalization): a. Systolic BP ?100 mmHg and no symptoms of hypotension in the 6 hours prior to randomization. b. No increase in intravenous diuretic dose for 6 hours prior to randomization. c. No intravenous vasodilators, including nitrates, within the last 6 hours prior to randomization. d. No intravenous inotropic drugs or mechanical circulatory support for 24 hours prior to randomization. 7. Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide). 8. Women of childbearing potential2 can only be included in the study if a pregnancy test is negative at screening and if they agree to use effective contraception which is consistent with local regulations regarding the methods for contraception3 for the duration of the study.