NCT06595290

Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University Medical Center Ho Chi Minh City (UMC) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Acute Heart Failure (AHF)
• Acute Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
OTHER	High intensity care	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.
OTHER	Usual care	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2029-01-01
• First posted: 2024-09-19
• Last updated: 2025-08-05

Locations

4 sites across 1 country: Vietnam