EUCTR2015-005757-12-DE进行中（未招募）1 期
Effect of IV iron (ferric carboxymaltose, Ferinject) on exercise tolerance,symptoms and quality of life in patients with heart failure with preservedejection fraction (HFpEF) and iron deficiency with and without anaemia - The FAIR-HFpEF Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient is willing to participate and provides written informed consent;
- •2.Age =18 years;
- •3.Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF) with LVEF =45% at screening or within 6 months prior to planned randomisation (assessed by echocardiography or MRI);
- •4.Ambulatory for at least 7 days with NYHA class II or III at time of randomisation (the screening visit can take place at the end of a
- •hospitalisation);
- •5.Treated with a diuretic;
- •6.Presence of atrial fibrillation (AF) at screening or randomisation is allowed in 2 out of 4 patients (calculated per centre);
- •7.At screening or randomisation, presence of one of the following
- •a)hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
- •b)raised plasma levels of natriuretic peptides in a patient with sinus rhythm (i.e. in patients without AF: NT-proBNP >300 pg/mL or BNP >100 pg/mL or MR-proANP >120 pmol/L; in patients with AF: NT-proBNP >600 pg/mL or BNP >200 pg/mL or MR-proANP >250 pmol/l)
- •8.Evidence of diastolic dysfunction at screening or randomisation, defined as:
- •a)E/E’ >13; OR
- •b)LA width =38 mm; OR
- •c)LA length =50 mm; OR
- •d)LA area =20 cm2; OR
- •e)LA volume =55 ml; OR
- •f) left atrial volume index >28 mL/m2;
- •9.Haemoglobin >9.0 g/dL and =14.0 g/dL (at screening);
- •10.ID with ferritin <100 ng/mL or ferritin 100-299 plus TSAT <20% (at screening);
- •11.6-minute-walking distance at baseline <450 m (average of the last 2 documented tests within 8 weeks prior to planned randomisation that also need to be within 20% of each other).
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Unable to sign informed consent
- •2. Any prior echocardiography measurement of LVEF <40%;
- •3. Clinical signs and symptoms of infection including fever >38°C;
- •4. SARS-CoV-2 infection
- •5. Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
- •6. Use of concurrent immunosuppressive therapy;
- •7. History of acquired iron overload or haemochromatosis (or a first relative with
- •haemochromatosis);
- •8. Known hypersensitivity to FCM or any other IV iron product;
- •9. Known bleeding or haemolytic anemia;
- •10. Presence of any condition that precludes exercise testing, such as decompensated
- •HF, significant musculoskeletal disease, unstable angina pectoris, obstructive
- •cardiomyopathy, severe uncorrected valvular disease, or uncontrolled bradyarrhythmias
- •or tachy-arrhythmias;
- •11. Probable alternative diagnoses that in the opinion of the investigator could account
- •for the patient’s HF symptoms such as severe obesity, primary pulmonary
- •hypertension, or chronic obstructive pulmonary disease (COPD); hence, patients with
- •the following are excluded:
- •a) Severe COPD, i.e. with known FEV1 <50%, requiring home oxygen therapy, or on
- •chronic oral steroid therapy;
- •b) body mass index =40.0 kg/m2;
- •12. Presence of uncontrolled atrial fibrillation with resting heart rate >110/min;
- •13. Presence of uncontrolled hypertension with blood pressure >160/100 mm Hg;
- •14. Renal replacement therapy;
- •15. Concurrent therapy with an erythropoiesis stimulating agent;
- •16. Known active malignancy;
- •17. Known HIV or active hepatitis infection;
- •18. Pregnancy;
- •19. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have
- •to exclude from the trial;
- •20. Lack of willingness to storage and disclosure of pseudonymous disease data in the
- •context of the clinical trial;
- •21. Participation in another clinical trial within previous 30 days and/or anticipated
- •participation in another trial during this study;
- •22. Inability to fully comprehend and/or perform study procedures in the investigator’s
- •23. Persons staying at an institution due to order by a national body or a court of law (in
- •accordance with the German Arzneimittelgesetz §40, Abs. 1, S. 3, Nr. 4);
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