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.
VN-RAPID is an open-labeled, multicenter, randomized study modeled after the STRONG-HF trial with the aim to evaluate the safety and efficacy of a standardized protocol of in-hospital initiation and rapid up-titration of all four pillars therapy for hospitalized acute heart failure (AHF) Asian patients with reduced ejection fraction (HFrEF). The study will enroll patients hospitalized with AHF with elevated NT-proBNP levels and not receiving optimal doses of oral HFrEF medications within 48 hours of discharge and are hemodynamically stable. These participants will be randomized in a 1:1 ratio to either usual care (named "usual care" arm) or intensification of treatment with all four pillars including RAS inhibitor (either ACEi or ARB or ARNi), beta-blocker, MRA and SGLT2i (named "high intensity care" arm). In the latter arm, the patients will be prescribed all four pillars before discharge with at least ¼ target dose. To ensure patient safety during the outpatient uptitration process, the high intensity care group will undergo thorough assessments at four follow-up appointments over a six-week period post-discharge, including physical examinations for signs and symptoms of congestion, laboratory tests such as NT-proBNP, serum creatinine, electrolytes. In consideration of the generally lower blood pressure observed in Asian populations, VN-RAPID establishes a target dose for RAS inhibitors and beta-blockers at 75% of the conventional target dose during outpatient uptitration. All participants will be followed through 180 days from randomization with 2 additional visits at 90-day and 180-day to assess clinical endpoints. Primary objective: To demonstrate that the VN-RAPID protocol-comprising in-hospital initiation and rapid outpatient uptitration of HFrEF four-pillar medical therapy, with lower target doses (75% of conventional) for RAS inhibitors and beta-blockers-is superior to usual care in reducing 180-day all-cause mortality or heart failure rehospitalization among Vietnamese patients hospitalized with acute heart failure and reduced ejection fraction. Secondary objectives: * To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 180-day all-cause mortality * To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 180-day heart failure rehospitalization * To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 90-day all-cause mortality or heart failure rehospitalization * To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing left ventricular remodeling by evaluation of LVEDV, LVEF on echocardiography at 90-day and 180-day * To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 90-day and 180-day congestion index score * To evaluate the safety and tolerability of the VN-RAPID protocol
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
This 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.
Patients 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.
An Giang Heart Hospital
Long Xuyen, An Giang, Vietnam
NOT_YET_RECRUITINGThong Nhat Hospital
Ho Chi Minh City, Ho Chi Minh City, Vietnam
NOT_YET_RECRUITINGUniversity Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, Vietnam
RECRUITINGQuang Tri Province Hospital
Đông Hà, Quang Tri, Vietnam
NOT_YET_RECRUITING180-day all-cause death or heart failure rehospitalization
Cumulative risk of either rehospitalization for heart failure or death at 180 days
Time frame: 180 days post-discharge
90-day all-cause mortality or heart failure rehospitalization
Cumulative risk of either rehospitalization for heart failure or death at 90 days
Time frame: 90 days post-discharge
180-day all-cause mortality
Cumulative risk of death at 180 days
Time frame: 180 days post discharge
180-day heart failure rehospitalization
Cumulative risk of heart failure rehospitalization at 180 days
Time frame: 180 days post discharge
Change in NT-proBNP at 180-day
Change of NT-proBNP levels from pre-discharge to 180 days post-discharge
Time frame: 180 days post-discharge
Change in left ventricular end-diastolic volume at 180-day
Change of left ventricular end-diastolic volume (LVEDV) from pre-discharge to 180 days post-discharge. LVEDV is measured in mL on echocardiography.
Time frame: 180 days post discharge
Change in left ventricular ejection fraction at 180-day
Change of left ventricular ejection fraction (LVEF) from pre-discharge to 180 days post-discharge. LVEF is measured in % on echocardiography using Simpson biplane method.
Time frame: 180 days post discharge
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