Actively Recruiting
Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction
Led by University Medical Center Ho Chi Minh City (UMC) · Updated on 2025-08-05
500
Participants Needed
4
Research Sites
178 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Ho Chi Minh City (UMC)
Lead Sponsor
M
Momentum Research, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospital admission with acute heart failure confirmed by clinical signs and tests
- Female or male patients aged 18 years or older
- Systolic blood pressure above 90 mmHg on at least two occasions
- Heart rate of 60 beats per minute or higher on at least two occasions
- Serum potassium level of 5.0 mmol/L or less
- Left ventricular ejection fraction of 40% or less by echocardiography
- Persistent congestion with NT-proBNP level of 1500 ng/L or higher before discharge
- Receiving suboptimal doses of heart failure medications at randomization (≤ 1/4 target dose RASi/ARNi, ≤ 1/4 target dose beta-blocker, ≤ 1/2 target dose MRA)
- Provided written informed consent
You will not qualify if you...
- Known intolerance to high doses of RASi/ARNi or beta-blockers
- Absolute contraindications to RASi/ARNi, beta-blockers, MRA, or SGLT2i
- Left ventricular ejection fraction greater than 40%
- Severe kidney disease with eGFR below 30 mL/min/1.73m2 or history of dialysis
- Significant lung disease causing major breathing problems or need for steroids
- Primary right heart failure such as pulmonary hypertension or recurrent pulmonary embolism
- Recent cardiac device implantation, bypass surgery, or heart attack within specified time frames
- Acute heart failure caused mainly by treatable conditions like severe arrhythmias or infections
- Untreated thyroid disease, active myocarditis, amyloidosis, or hypertrophic obstructive cardiomyopathy
- History of heart transplant or planned ventricular assist device
- Recent serious ventricular arrhythmias with fainting
- Significant heart valve problems except certain mitral or tricuspid issues
- Active infection during hospitalization requiring intravenous antibiotics
- Stroke or transient ischemic attack within 3 months
- Life-threatening liver disease
- Serious psychiatric, neurological disorder, cirrhosis, or cancer with life expectancy under 6 months
- Recent participation in other heart failure or investigational studies
- Expected hospital discharge more than 14 days after admission or to long-term care
- Unable to follow study procedures due to other medical, social, or financial issues
- Pregnant or nursing women
AI-Screening
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Trial Site Locations
Total: 4 locations
1
An Giang Heart Hospital
Long Xuyen, An Giang, Vietnam, 880000
Not Yet Recruiting
2
Thong Nhat Hospital
Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
Not Yet Recruiting
3
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
4
Quang Tri Province Hospital
Đông Hà, Quang Tri, Vietnam, 520000
Not Yet Recruiting
Research Team
V
Vu Hoang Vu, Ph.D M.D
CONTACT
N
Nam Thanh Hai Phan, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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