VN-RAPID is an open-label, multicenter, randomized controlled trial evaluating the safety and efficacy of in-hospital initiation and rapid up-titration of four-pillar therapy for hospitalized Asian patients with acute heart failure (AHF) and reduced ejection fraction (HFrEF). The study compares a standardized protocol of intensified treatment (high-intensity care arm) with usual care in patients with elevated NT-proBNP levels who are not on optimal HFrEF medications. The high-intensity care arm involves initiation of all four pillars of HFrEF therapy (RAS inhibitor, beta-blocker, MRA, and SGLT2i) before discharge, followed by a structured 6-week outpatient up-titration process with frequent follow-ups. The study aims for 75% of target doses for RAS inhibitors and beta-blockers, considering the lower blood pressure tendency in Asian populations. Participants will be followed for 180 days to assess clinical outcomes.
Hospital admission with diagnosis of acute heart failure assessed by clinical signs and symptoms of congestion and radiographic, biological tests (if admitted with acute coronary syndrome, required at least Killip class II or clear evidence of congestion on admission assessed by chest x-ray or lung ultrasound and/or pulmonary congestion requiring intravenous treatment)
Female or male patients ≥ 18 years old
Systolic blood pressure > 90 mmHg (at least 2 measurements on 2 different occasions) and
Heart rate ≥ 60 bpm (at least 2 measurements on 2 different occasions) and
Clearly documented intolerance to high doses of RASi/ARNi or beta-blockers
Absolute contraindication to usage of RASi/ARNi or beta-blocker or MRA or SGLT2i as per ESC 2021/ACC 2022 Heart failure guideline
LVEF >40% assessed by echocardiography on the latest measurement prior to discharge
Renal disease or eGFR < 30 mL/min/1.73m2 (as estimated by the CKD-EPI 2021 or the simplified MDRD) at Screening or history of dialysis.
Parallel
High intensity care
Other interventionThis arm follows a structured algorithm for initiating and uptitrating all four pillars of HFrEF oral medications post-randomization (pre-discharge) and during at least 4 visits over 6 weeks post-discharge.
Usual care
Other interventionPatients will be managed by their cardiologist according to their usual practice. Follow-up appointments will be scheduled as per the cardiologist\'s instructions. Participants will return to the recruiting study site for clinical outcome assessment by study investigators at 90 and 180 days post-discharge.
180-day all-cause death or heart failure rehospitalization
Cumulative risk of either rehospitalization for heart failure or death at 180 days
90-day all-cause mortality or heart failure rehospitalization
Cumulative risk of either rehospitalization for heart failure or death at 90 days
180-day all-cause mortality
Cumulative risk of death at 180 days
180-day heart failure rehospitalization
Cumulative risk of heart failure rehospitalization at 180 days
Change in NT-proBNP at 180-day
Change of NT-proBNP levels from pre-discharge to 180 days post-discharge
Change in congestion score at 180-day
Change of congestion score from pre discharge to 180 days post discharge. The congestion score was calculated as a sum of points gained for: * Presence (1 point)/absence (0 points) of edema * Presence (1 point)/absence (0 points) of pulmonary rales * JVP lower than 6 cm (0 points)/equal to or greater than 6 cm (1 point) A congestion score of 0 was defined as a criterion for successful decongestion.
Change on lung ultrasound at 180-day
Change of the number of B lines measured at pre discharge to 180 days post discharge. B lines are measured on lung ultrasound using a 4-zone scanning protocol. 0 B line indicates no congestion.
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University Medical Center Ho Chi Minh City (UMC)
Lead sponsor
Momentum Research, Inc.
Collaborator
INSERM UMR-942, Paris, France
Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborator
