Acute Heart Failure (AHF)VN-RAPIDNCT06595290
Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction
A study testing High intensity care in people with Acute Heart Failure (AHF) and Acute Heart Failure With Reduced Ejection Fraction, run by University Medical Center Ho Chi Minh City (UMC) at 4 sites in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Heart Failure (AHF), Acute Heart Failure With Reduced Ejection Fraction
- What is being tested?
- High intensity care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesVietnam
- Study dates
- 1 Aug 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
- AHF triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response \>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \<45 beats per minute), infection, severe anemia, pulmonary embolism, exacerbation of COPD, planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.
- 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.
- Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening
- Discharge for the AHF hospitalization anticipated to be \> 14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at within 2 days prior to anticipated discharge.
- Inability to comply with all study requirements, due to major comorbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures
- Pregnant or nursing (lactating) women.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam4 sites, 4 recruiting
- Not yet recruiting
Quang Tri Province Hospital
Đông Hà, Quang Tri, 520000
- Not yet recruiting
Thong Nhat Hospital
Ho Chi Minh City, Ho Chi Minh City, 700000
Tan Van Nguyen, Ph.D M.D, +84903739273, nguyenvtan10@ump.edu.vn
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, 700000
Vu Hoang Vu, PhD MD, +84908431304, vu.vh@umc.edu.vn
Nam Thanh Hai Phan, M.D, +84937728990, nam.pth2@umc.edu.vn
- Not yet recruiting
An Giang Heart Hospital
Long Xuyen, An Giang, 880000
Ut Van Be Nguyen, M.D
About this study
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.
Read the detailed description
VN-RAPID is an open-labeled, multicenter, randomized study modeled after the STRONG-HF trial with the aim to evaluate the safety and efficacy of a standardized protocol of in-hospital initiation and rapid up-titration of all four pillars therapy for hospitalized acute heart failure (AHF) Asian patients with reduced ejection fraction (HFrEF). The study will enroll patients hospitalized with AHF with elevated NT-proBNP levels and not receiving optimal doses of oral HFrEF medications within 48 hours of discharge and are hemodynamically stable. These participants will be randomized in a 1:1 ratio to either usual care (named "usual care" arm) or intensification of treatment with all four pillars including RAS inhibitor (either ACEi or ARB or ARNi), beta-blocker, MRA and SGLT2i (named "high intensity care" arm). In the latter arm, the patients will be prescribed all four pillars before discharge with at least ¼ target dose. To ensure patient safety during the outpatient uptitration process, the high intensity care group will undergo thorough assessments at four follow-up appointments over a six-week period post-discharge, including physical examinations for signs and symptoms of congestion, laboratory tests such as NT-proBNP, serum creatinine, electrolytes. In consideration of the generally lower blood pressure observed in Asian populations, VN-RAPID establishes a target dose for RAS inhibitors and beta-blockers at 75% of the conventional target dose during outpatient uptitration. All participants will be followed through 180 days from randomization with 2 additional visits at 90-day and 180-day to assess clinical endpoints.
Primary objective:
To demonstrate that the VN-RAPID protocol-comprising in-hospital initiation and rapid outpatient uptitration of HFrEF four-pillar medical therapy, with lower target doses (75% of conventional) for RAS inhibitors and beta-blockers-is superior to usual care in reducing 180-day all-cause mortality or heart failure rehospitalization among Vietnamese patients hospitalized with acute heart failure and reduced ejection fraction.
Secondary objectives:
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 180-day all-cause mortality
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 180-day heart failure rehospitalization
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 90-day all-cause mortality or heart failure rehospitalization
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing left ventricular remodeling by evaluation of LVEDV, LVEF on echocardiography at 90-day and 180-day
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 90-day and 180-day congestion index score
- To evaluate the safety and tolerability of the VN-RAPID protocol
- Being tested
- High intensity care, Usual care
- Keywords
- HFrEF, STRONG-HF, Acute heart failure, Rapid uptitration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity careOther
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High intensity care |
What is being measured
The primary outcome is the main question the study is designed to answer.
180-day all-cause death or heart failure rehospitalization
Cumulative risk of either rehospitalization for heart failure or death at 180 days
Measured: 180 days post-discharge
Secondary outcomes (6)
90-day all-cause mortality or heart failure rehospitalization
Cumulative risk of either rehospitalization for heart failure or death at 90 days
Measured: 90 days post-discharge
180-day all-cause mortality
Cumulative risk of death at 180 days
Measured: 180 days post discharge
180-day heart failure rehospitalization
Cumulative risk of heart failure rehospitalization at 180 days
Measured: 180 days post discharge
Change in NT-proBNP at 180-day
Change of NT-proBNP levels from pre-discharge to 180 days post-discharge
Measured: 180 days post-discharge
Change in left ventricular end-diastolic volume at 180-day
Change of left ventricular end-diastolic volume (LVEDV) from pre-discharge to 180 days post-discharge. LVEDV is measured in mL on echocardiography.
Measured: 180 days post discharge
Change in left ventricular ejection fraction at 180-day
Change of left ventricular ejection fraction (LVEF) from pre-discharge to 180 days post-discharge. LVEF is measured in % on echocardiography using Simpson biplane method.
Measured: 180 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Collaborators
- Momentum Research, Inc., INSERM UMR-942, Paris, France, University of Medicine and Pharmacy at Ho Chi Minh City
- Responsible party
- Principal investigator, Vu Hoang Vu, University Medical Center Ho Chi Minh City (UMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595290
- Sponsor's protocol ID
- DHYD-VNRAPID
- Acronym
- VN-RAPID
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT06595290
- Acronym / sponsor ID
- VN-RAPID / DHYD-VNRAPID
- Keywords
- HFrEF, STRONG-HF, Acute heart failure, Rapid uptitration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Collaborators
- Momentum Research, Inc., INSERM UMR-942, Paris, France, University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
VN-RAPID is an open-labeled, multicenter, randomized study modeled after the STRONG-HF trial with the aim to evaluate the safety and efficacy of a standardized protocol of in-hospital initiation and rapid up-titration of all four pillars therapy for hospitalized acute heart failure (AHF) Asian patients with reduced ejection fraction (HFrEF). The study will enroll patients hospitalized with AHF with elevated NT-proBNP levels and not receiving optimal doses of oral HFrEF medications within 48 hours of discharge and are hemodynamically stable. These participants will be randomized in a 1:1 ratio to either usual care (named "usual care" arm) or intensification of treatment with all four pillars including RAS inhibitor (either ACEi or ARB or ARNi), beta-blocker, MRA and SGLT2i (named "high intensity care" arm). In the latter arm, the patients will be prescribed all four pillars before discharge with at least ¼ target dose. To ensure patient safety during the outpatient uptitration process, the high intensity care group will undergo thorough assessments at four follow-up appointments over a six-week period post-discharge, including physical examinations for signs and symptoms of congestion, laboratory tests such as NT-proBNP, serum creatinine, electrolytes. In consideration of the generally lower blood pressure observed in Asian populations, VN-RAPID establishes a target dose for RAS inhibitors and beta-blockers at 75% of the conventional target dose during outpatient uptitration. All participants will be followed through 180 days from randomization with 2 additional visits at 90-day and 180-day to assess clinical endpoints.
Primary objective:
To demonstrate that the VN-RAPID protocol-comprising in-hospital initiation and rapid outpatient uptitration of HFrEF four-pillar medical therapy, with lower target doses (75% of conventional) for RAS inhibitors and beta-blockers-is superior to usual care in reducing 180-day all-cause mortality or heart failure rehospitalization among Vietnamese patients hospitalized with acute heart failure and reduced ejection fraction.
Secondary objectives:
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 180-day all-cause mortality
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 180-day heart failure rehospitalization
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 90-day all-cause mortality or heart failure rehospitalization
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing left ventricular remodeling by evaluation of LVEDV, LVEF on echocardiography at 90-day and 180-day
- To demonstrate the superiority of the VN-RAPID protocol, compared to usual HFrEF care, in reducing 90-day and 180-day congestion index score
- To evaluate the safety and tolerability of the VN-RAPID protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual carePatients 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. |
| High intensity care | Experimental | Other: High intensity careThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity careThis 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 |
| Usual carePatients 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 |
Primary outcome
180-day all-cause death or heart failure rehospitalization
Time frame: 180 days post-discharge
Cumulative risk of either rehospitalization for heart failure or death at 180 days
6 secondary outcomes
90-day all-cause mortality or heart failure rehospitalization
Time frame: 90 days post-discharge
180-day all-cause mortality
Time frame: 180 days post discharge
180-day heart failure rehospitalization
Time frame: 180 days post discharge
Change in NT-proBNP at 180-day
Time frame: 180 days post-discharge
Change in left ventricular end-diastolic volume at 180-day
Time frame: 180 days post discharge
Change in left ventricular ejection fraction at 180-day
Time frame: 180 days post discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity care in people with Acute Heart Failure (AHF) and Acute Heart Failure With Reduced Ejection Fraction, run by University Medical Center Ho Chi Minh City (UMC) at 4 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vu Hoang Vu, Ph.D M.D (+84908431304, vu.vh@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
180-day all-cause death or heart failure rehospitalization (time frame: 180 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.