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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• At randomization:

‣ 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

⁃ Serum potassium ≤ 5.0 mmol/L

• Left ventricular ejection fraction (LVEF) ≤ 40% assessed locally by Simpson's Biplane method via echocardiography (if multiple LVEF measurements, the last one performed prior to randomization should be considered as the qualifying measurement)

• Persistent congestion at the time of randomization with pre-discharge NT-proBNP ≥ 1500 ng/L

• HFrEF medications at randomization:

‣ ≤ ¼ RASi/ARNi target dose and

⁃ ≤ ¼ beta-blocker target dose and

⁃ ≤ ½ MRA dose

• Obtained written informed consent form

Locations
Other Locations
Viet Nam
Quang Tri Province Hospital
NOT_YET_RECRUITING
Đông Hà
Thong Nhat Hospital
NOT_YET_RECRUITING
Ho Chi Minh City
University Medical Center Ho Chi Minh City
RECRUITING
Ho Chi Minh City
An Giang Heart Hospital
NOT_YET_RECRUITING
Long Xuyen
Contact Information
Primary
Vu Hoang Vu, Ph.D M.D
vu.vh@umc.edu.vn
+84908431304‬
Backup
Nam Thanh Hai Phan, M.D
nam.pth2@umc.edu.vn
+84937728990
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 500
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Momentum Research, Inc., INSERM UMR-942, Paris, France, University of Medicine and Pharmacy at Ho Chi Minh City
Leads: University Medical Center Ho Chi Minh City (UMC)

This content was sourced from clinicaltrials.gov