Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595290
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VN-RAPID
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
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 11 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 ΒΌ 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None