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

Launched by UNIVERSITY MEDICAL CENTER HO CHI MINH CITY (UMC) · Sep 10, 2024

Keywords

ClinConnect Summary

The VN-RAPID trial is a study looking at a new approach to treating patients with acute heart failure who have a reduced ability of the heart to pump blood. The goal is to see if starting a specific combination of heart failure medications while patients are in the hospital, and then adjusting the doses in follow-up visits, can improve their health outcomes compared to standard care. This trial is designed for patients aged 18 and older who have been hospitalized for heart failure and have certain levels of heart function and symptoms.

If eligible, participants can expect to receive either the new intensified treatment or the usual care during their hospital stay. After leaving the hospital, they will have regular check-ups over six weeks to ensure their medication doses are increased as needed. The study will follow participants for about six months to see how well this approach works. It's important to note that the trial is not yet recruiting participants, and those interested should check if they meet specific criteria, such as having a certain level of heart function and not being on optimal heart failure medications before entering the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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)
• • 2. Female or male patients ≥ 18 years old
• 3. At randomization:
• • 1. Systolic blood pressure \> 90 mmHg (at least 2 measurements on 2 different occasions) and
• • 2. Heart rate ≥ 60 bpm (at least 2 measurements on 2 different occasions) and
• • 3. Serum potassium ≤ 5.0 mmol/L
• • 4. 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)
• • 5. Persistent congestion at the time of randomization with pre-discharge NT-proBNP ≥ 1500 ng/L
• 6. HFrEF medications at randomization:
• • 1. ≤ ¼ RASi/ARNi target dose and
• • 2. ≤ ¼ beta-blocker target dose and
• • 3. ≤ ½ MRA dose
• • 7. Obtained written informed consent form
• Exclusion Criteria:
• • 1. Clearly documented intolerance to high doses of RASi/ARNi or beta-blockers
• • 2. Absolute contraindication to usage of RASi/ARNi or beta-blocker or MRA or SGLT2i as per ESC 2021/ACC 2022 Heart failure guideline
• • 3. LVEF \>40% assessed by echocardiography on the latest measurement prior to discharge
• • 4. 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.
• • 5. 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.
• • 6. Implantation of cardiac resynchronization device or underwent coronary artery bypass graft surgery within 3 months
• • 7. 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.
• • 8. 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.
• • 9. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
• • 10. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
• • 11. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
• • 12. 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.
• • 13. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics.
• • 14. Stroke or TIA within the 3 months prior to Screening.
• • 15. Primary liver disease considered to be life threatening.
• • 16. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months.
• • 17. 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
• • 18. 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.
• • 19. 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
• • 20. Pregnant or nursing (lactating) women.