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New treatment option for Acute Heart Failure (AHF)
Official title Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction
ClinicalTrials.gov ID: NCT06595290
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Hospital admission with diagnosis of acute heart failure assessed by clinical signs and symptoms of congestion and radiographic, biological tests (if...
- 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
You likely can't join 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...
- Implantation of cardiac resynchronization device or underwent coronary artery bypass graft surgery within 3 months
See the full eligibility criteria
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Pregnant or nursing (lactating) women.
The study team makes the final eligibility decision.
Where it's taking place
- Long Xuyen, An Giang, Vietnam
- Ho Chi Minh City, Ho Chi Minh City, Vietnam
- Đông Hà, Quang Tri, Vietnam
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Xuyen, An Giang, Vietnam; Ho Chi Minh City, Ho Chi Minh City, Vietnam; Đông Hà, Quang Tri, Vietnam. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.