Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653725
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure a Randomized Clinical Trial KETO-AHF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
KETO-AHF
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled trial to investigate the clinical efficacy of treatment with exogenous dietary ketone supplement containing 13-butanediol in patients hospitalized with acute heart failure AHF potentially leading to better clinical outcomes
Detailed Description:
Acute heart failure AHF is life-threatening with a 30-day mortality rate between 10 and 50 especially in patients with cardiogenic shock Current medical treatments have not shown a survival benefit in randomized trials highlighting the need for new therapies Ketone bodies particularly 3-hydroxybutyrate 3-OHB are vital for energy in the heart and brain during stress Elevated 3-OHB levels from exogenous sources such as ketone esters or 13-butanediol enhance organ perfusion and improve cardiac function In chronic heart failure HF 3-OHB infusion increases cardiac output and left ventricular ejection fraction LVEF without excess oxygen consumption supporting its role as an efficient energy source Short-term ketone ester treatment has been shown to improve hemodynamics reduce NT-proBNP and enhance physical performance in heart failure with reduced ejection fraction HFrEF patients In AHF patients ketone ester improved cardiac output LVEF and filling pressures Emerging evidence suggests that 13-butanediol supplements may sustain ketosis longer offering potential for practical dosing in the acute phase of heart failure
This proposal aims to study the clinical efficacy of treatment with exogenous dietary ketone supplement containing 13-butanediol in patients hospitalized with AHF
The primary hypothesis is that in patients hospitalized with AHF a 30-day treatment with 13- butanediol has beneficial clinical effects as compared with placebo Clinical benefit is defined as a hierarchical composite of death heart failure HF events change from baseline in the 6-minute walk test 6MWT and change from baseline in NT-proBNP at 30 days as assessed using win ratio statistics
This proposal aims to study the clinical efficacy of treatment with exogenous dietary ketone supplement containing 13-butanediol in patients hospitalized with AHF
The primary hypothesis is that in patients hospitalized with AHF a 30-day treatment with 13- butanediol has beneficial clinical effects as compared with placebo Clinical benefit is defined as a hierarchical composite of death heart failure HF events change from baseline in the 6-minute walk test 6MWT and change from baseline in NT-proBNP at 30 days as assessed using win ratio statistics
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