Pathophysiological relevance of IRON deficiency and related mitochondrial dysfunction in Heart Failure with Preserved Ejection Fraction (IRON-HFpEF) - IRON-HFpEF

Amsterdam UMC, location VUmc0 个研究点目标入组 45 人开始时间: 2019年10月7日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•1. Diagnosis of heart failure with preserved ejection fraction
•a. signs/and symptoms of heartfailure (NYHA II or higher)
•b. Left ventricular ejection fraction =50%
•c. evidence of left ventricular diastolic dysfunction:
•-pulmonary capillary wedge pressure (PCWP) at rest = 15mmHg and/or PCWP during exercise = 25mmHg
•or if no right heart catheterisation has been performed:
•-HFpEf score = 6;
•-diastolic dysfunction grade II or higher on echocardiogram + NTproBNP of >125 pg/mL
•d. no other significant cardiac (e.g. significant valvular disease) or extra-cardiac con-dition (e.g. severe COPD) that explains symptoms
•2. Optimal medical treatment
•3. Clinically stable
•4. Iron deficient (ferritin <100pg/L or ferritin 100-300pg/L and transferrin saturation or TSAT <20%).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. No informed consent
•2. Contra indication ferric carboxy maltose
•a. known allergic reaction to product; b. clinical signs of an acute infection; c. conditions with high risk for an allergic reaction (severe asthma or eczema, systemic lupus erhytematosus, rheumatoid arthtritis or concurrent use of significant immunosuppressive therapy); severe liver disease
•3. History of (previous 2 months) or planned use of intravenous/oral iron, erythro-poietin or blood transfusion
•4. Acute coronary syndrome, TIA/CVA, PCI/CABG/valve replacement or any major surgery within 3 months prior;
•5. Unable to undergo the complete study protocol (i.e. right heart catheterisation, 6 minute walk distance)

发起方

Amsterdam UMC, location VUmc