Study of the Prevalence of Iron Deficiency Among Hospitalized Patients With HFpEF and the Impact of Ferinject® on Indicators of Quality of Life, Functional Status in Patients With Iron Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary Outcome (Combined)
研究概览
简要总结
Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.
详细描述
The prevalence of HFpEF among patients admitted to cardiology hospitals will be studied. The study will include patients with NYHA II-III who have signed an informed consent that meets the inclusion/exclusion criteria. The effectiveness of intravenous administration of iron carboxymaltose (Ferinject ® ) to correct iron deficiency and improve the clinical course of HFpEF will be evaluated. A group without iron deficiency will be recruited as a control group (n=30).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent to participate in the study;
- •In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF);
- •Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and/or functional disorders of the heart consistent with the presence of LV diastolic dysfunction/increased LV filling pressure, including elevated levels of natriuretic peptide;
- •Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%;
- •Screening haemoglobin (Hb) at the time of switching on ( 90-150 g/l).
排除标准
- •Uncontrolled arterial hypertension;
- •Аnemia not related to iron deficiency;
- •Аnemia with a hemoglobin level of less than 90 g/l;
- •Less than 1 year after acute myocardial infarction;
- •Less than 1 year after acute cerebral circulation disorder;
- •Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology;
- •Chronic alcoholism (including alcoholic heart disease), mental disorders;
- •Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml/min/1.73 m2);
- •Known active infection, clinically significant bleeding, active malignancy;
- •Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);
- •Severe bronchial asthma, COPD in the acute stage;
- •Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;
- •Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.
研究组 & 干预措施
Experimental: 1
Drug: Ferinject ® (Ferric carboxymaltose)
干预措施: Ferinject (Drug)
Comparison Group: 2
Diet therapy, without drug therapy
干预措施: Diet therapy (Other)
结局指标
主要结局
Primary Outcome (Combined)
时间窗: 12 months
Change of 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ) (0-100 points)+change in test distance with a 6-minute walk (6MWD - 150 meters or more) by 35 meters or more. An increase in the number of points by 5 on the Kansas City Cardiomyopathy Questionnaire scale, increasing the distance on the 6-minute walk test by 35 meters means a better result. The absence of changes/decrease in the number of points on the Kansas City Cardiomyopathy Questionnaire scale, the absence of changes/decrease in the distance in the 6-minute walking test means the worst result.
次要结局
- Hospitalization for heart failure and death from all causes(12 months)
- Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points).(6 months)
- Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters(6 months)
- Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes)(6 months)
- Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points)(6 months)