Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06595290

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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