Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270498
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-02-10
Brief Title:
Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
Sponsor:
Raffaele De Caterina
Organization:
Azienda Ospedaliero Universitaria Pisana
Study Overview
Official Title:
Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure a Randomized Placebo-controlled Trial RISE-HF
Status:
RECRUITING
Status Verified Date:
2024-05
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:
RISE-HF
Brief Summary:
The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure HF and iron deficiency ID
The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity assessed by six-minute walk test and quality of life assessed by Kansas City Cardiomyopathy Questionnaire compared with placebo
One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo
The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity assessed by six-minute walk test and quality of life assessed by Kansas City Cardiomyopathy Questionnaire compared with placebo
One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo
Detailed Description:
Based on clinical trials treatment with intravenous iron improves symptoms exercise capacity and may reduce HF hospitalizations in patients with HF and ID On the contrary treatment of ID with oral iron has no effect on exercise capacity High hepcidin levels prevent oral intestinal absorption and blunt the response to oral iron administration Sucrosomial iron SI consists of a nucleus of ferric pyrophosphate with an envelope of sucrose ester of fatty acids which promotes intestinal absorption through paracellular and lymphatic routes independent of hepcidin In contrast with intravenous iron infusion administration of oral iron may not promote oxidative stress since the intestinal iron absorption prevent the formation of labile non-transferrin bound plasma iron
The study will investigate the effect of oral SI supplementation on exercise capacity assessed by six-minute walk test and quality of life assessed by Kansas City Cardiomyopathy Questionnaire compared with placebo in patients with HF a left ventricular ejection fraction LVEF lt50 Iron deficiency was defined as transferrin saturation TSAT lt20
The study will investigate the effect of oral SI supplementation on exercise capacity assessed by six-minute walk test and quality of life assessed by Kansas City Cardiomyopathy Questionnaire compared with placebo in patients with HF a left ventricular ejection fraction LVEF lt50 Iron deficiency was defined as transferrin saturation TSAT lt20
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