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

NCT06595290 | Recruiting DMC

• 1 other identifier: DHYD-VNRAPID
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Keywords

HFrEF; STRONG-HF; Acute heart failure; Rapid uptitration

Outcome Measures

Primary Outcomes (1)

• 180-day all-cause death or heart failure rehospitalization

  Cumulative risk of either rehospitalization for heart failure or death at 180 days

  180 days post-discharge

Secondary Outcomes (6)

• 90-day all-cause mortality or heart failure rehospitalization

  90 days post-discharge

• 180-day all-cause mortality

  180 days post discharge

• 180-day heart failure rehospitalization

  180 days post discharge

• Change in NT-proBNP at 180-day

  180 days post-discharge

• Change in left ventricular end-diastolic volume at 180-day

  180 days post discharge

Other Outcomes (2)

• Change in congestion score at 180-day

  180 days post discharge

• Change on lung ultrasound at 180-day

  180 days post discharge

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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.

Other: Usual care

High intensity care

EXPERIMENTAL

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: High intensity care

Interventions

High intensity care OTHER

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.

High intensity care

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.
• Implantation of cardiac resynchronization device or underwent coronary artery bypass graft surgery within 3 months
• Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous coronary intervention (PCI), within 1 month prior to Screening.
• Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
• History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
• Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
• Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract.
• Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics.
• Stroke or TIA within the 3 months prior to Screening.
• Primary liver disease considered to be life threatening.
• Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months.

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead
• Momentum Research, Inc.: collaborator
• INSERM UMR-942, Paris, France: collaborator
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

Study Sites (4)

An Giang Heart Hospital

Long Xuyen, An Giang, 880000, Vietnam

NOT YET RECRUITING

Thong Nhat Hospital

Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

NOT YET RECRUITING

University Medical Center Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

RECRUITING

Quang Tri Province Hospital

Đông Hà, Quang Tri, 520000, Vietnam

NOT YET RECRUITING

Central Study Contacts

Vu Hoang Vu, Ph.D M.D

CONTACT

+84908431304‬; vu.vh@umc.edu.vn

Nam Thanh Hai Phan, M.D

CONTACT

+84937728990; nam.pth2@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interventional Cardiology Department, PhD MD

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (4)