Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05991128
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-07-14
Brief Title:
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Sponsor:
China-Japan Friendship Hospital
Organization:
China-Japan Friendship Hospital
Study Overview
Official Title:
The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life a Randomised Parallel-group Double-blind Placebo Controlled Trial COREVIVE-HFpEF
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COREVIVE-HFpEF
Brief Summary:
This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 09 as placebo
Detailed Description:
Acute heart failure is very common medical problem Despite many clinical trials conducted to date in these patients the rates of adverse outcomes remain very high Previous comorbidities may account for it Approximately 80 of patients hospitalized with AHF suffered from a combination of iron deficiency A decline in exercise capacity may occur under this condition Some research studies have suggested that giving CHF patients intravenous iron improves symptoms in the short term It is unknown however whether correcting iron deficiency is beneficial to patients with AHF to improve excise capacity and whether it improves quality of life and accelerate recovery from acute duration This study will help us answer these key questions
This is an investigator-initiated randomised parallel group double-blind placebo-controlled trial evaluating the excise capacity improvement of using ferric derimaltose versus placebo in hospitalized patients with acute heart failure with preserved ejection fraction before discharge
Participants will be assessed daily using 6-minute walking test after IV iron injection until discharge from hospital especially focus on the change from baseline to the 3rd day Some questionnaire are also conducted to evaluate the self-reported status Participants will be followed up at 2 weeks and 4 weeks
The primary and secondary endpoints will be examined in subgroups predefined by baseline variables reflecting demography Hb level etiology of HF left ventricular ejection fraction natriuretic peptide index of iron metabolism eGFR and others
This is an investigator-initiated randomised parallel group double-blind placebo-controlled trial evaluating the excise capacity improvement of using ferric derimaltose versus placebo in hospitalized patients with acute heart failure with preserved ejection fraction before discharge
Participants will be assessed daily using 6-minute walking test after IV iron injection until discharge from hospital especially focus on the change from baseline to the 3rd day Some questionnaire are also conducted to evaluate the self-reported status Participants will be followed up at 2 weeks and 4 weeks
The primary and secondary endpoints will be examined in subgroups predefined by baseline variables reflecting demography Hb level etiology of HF left ventricular ejection fraction natriuretic peptide index of iron metabolism eGFR and others
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None