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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Medical Center Ho Chi Minh City (UMC)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • High intensity care
  • Usual care

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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