NCT03344523Unknown4 期
A Randomized, Double-blind, Multi-center Clinical Trial Prospectively Evaluating Iron Protein Succinylate Oral Solution in Treating Patients With Chronic Heart Failure and Iron Deficiency
Lee's Pharmaceutical Limited0 个研究点目标入组 600 人开始时间: 2018年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 主要终点
- The change of 6 Minute walk distances
研究概览
简要总结
This study aims to evaluate the effect of standard heart failure therapy plus oral solution with protein succinylate iron compared to placebo on the primary end point of 6 minute walk distance at 24th week in patients with chronic ejection fraction reduction heart failure and iron deficiency.
详细描述
This clinical trial was designed as a multicenter, prospective, randomized, double-blind controlled study. Patients were randomly divided into one of two treatment groups:
Control group: standard treatment + placebo（1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）.
Test group: standard treatment + Iron protein succinylate oral solution (1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）.
Sample size calculation is according to the change of 6 Minute walk distance from the baseline at 24 weeks, it is estimated the mean difference between two groups is 20 meter, standard deviation 80 meter, statistical power 80%, type I error 0.05, follow up loss 15%，estimated total sample size 600.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent form;
- •Between 18 to 80 years old, male or female;
- •Patients with chronic ejection fraction reduction heart failure, has been accepted the medication recommended by the Guidelines for treatment of heart failure in China (2014) for at least 4 weeks (that comply with the following requirements): if there is no contraindications or intolerance, patients should receive the renin angiotensin aldosterone system inhibitors, B blockers, and no dose adjustment within 4 weeks (not including diuretics). For patients who do not follow the guidelines for the use and titration of the renin angiotensin aldosterone system inhibitor and B blocker drugs, the cause should be recorded;
- •LVEF< 40% (determined by Simpson method) (valid for one week before randomization);
- •NYHA heart function II-III Grade;
- •NT-proBNP>400pg/ml, it should be .900pg/ml at atrial fibrillation;
- •Upper limit of hemoglobin: women less than 120g/L, men less than 130g/L. Lower limit of hemoglobin: more than 90g/L for both men and women. Accompanied by Iron deficiency (iron deficiency is defined as serum ferritin<100ug/L, or serum ferritin between 100~300ug/L with transferrin saturation (Tsat) <20%);
- •Capable of 6 Minute walk test.
排除标准
- •Patients with significant bleeding: gastrointestinal bleeding, menorrhagia, history of gastrointestinal bleeding and no evidence of gastrointestinal disease healing;
- •History of oral iron supplementation and intolerance;
- •History of acquired iron overload;
- •Exclude if receiving erythropoietin, intravenous iron, transfusion therapy and oral iron (including iron contained in compound vitamins or other compound medicine) ≧75mg/day within 6 weeks before enrollment;
- •Patients in urgent need of blood transfusion;
- •VtaminB12 and/or folate deficiency, unless correctable; and Non-iron deficiency anemia;
- •Severe renal insufficiency（eGFR < 20ml/min/1.73m2, MDRD formula）, renal anemia; or history of kidney dialysis, need of kidney dialysis at present or in 6 months;
- •Chronic liver disease, cirrhosis, active hepatitis, transaminases (increase of alanine aminotransferase and aspartate aminotransferase 3 times above the normal upper limit. Total bilirubin 3 times higher than the normal upper limit);
- •Intestinal diseases which affect iron absorption such as inflammatory bowel disease and chronic pancreatitis;
- •Active infection;
- •History of syncope within 3 months, diagnosed as cardiogenic shock over the past 1 months;
- •Active myocarditis, constrictive pericarditis and other pericardial diseases;
- •Acute decompensated heart failure with unstable hemodynamics;
- •Symptomatic bradycardia or second or third-degree cardiac conduction block with no pacemaker installed;
- •Severe chronic obstructive pulmonary disease, pulmonary heart disease, severe pulmonary vascular disease, pulmonary hypertension caused by autoimmune diseases and any type of severe pulmonary hypertension;
- •Valvular heart disease and congenital heart disease without operation; hypertrophic cardiomyopathy, restricted cardiomyopathy, and other secondary cardiomyopathy;
- •Patients with malignancy;
- •Patients combined with other organ diseases such as hematopoietic system, nervous system, endocrine system like thyroid, and combined with psychosis;
- •There is uncontrolled hypertension, systolic pressure is greater than 180mmHg and/or diastolic pressure is greater than 110mmHg;
- •Heart rate ≥ 130 times/minute before randomization, or malignant ventricular arrhythmia affecting hemodynamic;
- •Neuromuscular disease, disability or other non-cardiac causes influencing the performance of 6 Minute walk test;
- •Occurred within 3 months: acute coronary syndrome, stroke, transient cerebral ischemic attack; cardiac, carotid artery or other major vascular surgery; percutaneous coronary intervention (PCI) or carotid artery angioplasty or coronary bypass surgery and other cardiac surgery; or scheduled for percutaneous intervention and surgery surgical treatment within 6 months;
- •Has been implanted pacemaker/defibrillator (CRT-P/D) of cardiac resynchronization therapy within 6 months, or the intention to implant a similar device within 6 months after randomization;
- •Has been received major surgery within 6 months prior to randomization, or intend to receive major surgical treatment within 6 months;
- •History of heart transplantation or waiting for transplantation or using a left ventricular assist device (LVAD) or a heart transplant intention (waiting for transplantation) or intend to use VAD over the next 6 months;
- •Nursing or pregnant women, or women of childbearing age without contraception, or patients planned pregnancy in 6 months;
- •History of major organ transplant (such as lung, liver, bone marrow, kidney)
- •Patients have been involved or to be involved in other clinical trials within one month;
- •Patients cannot understand the informed consent form or cannot make decisions or of poor compliance;
- •Patients judged as unsuitable for the study and life expectancy less than 1 year by investigators.
研究组 & 干预措施
standard treatment + Iron succinylate
Experimental
1 bottle orally, twice daily, take orally before meals
干预措施: Iron protein succinylate oral solution (Drug)
standard treatment + Iron succinylate
Experimental
1 bottle orally, twice daily, take orally before meals
干预措施: standard treatment (Other)
standard treatment + placebo
Placebo Comparator
1 bottle orally, twice daily, take orally before meals
干预措施: standard treatment (Other)
结局指标
主要结局
The change of 6 Minute walk distances
时间窗: 24 week
The change of 6 Minute walk distances compared to baseline after patients receiving 24 week treatment.
次要结局
- Cardiovascular death or heart failure re-hospitalization after patients receiving 24 week treatment(24 week)
- Change of 6 Minute walk distance after patients receiving 16 week treatment(16 week)
- Variety of overall status score（PGA）after patients receiving 24 week treatment(24 week)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) rating change after patients receiving 24 week treatment(24 week)
- Change of blood NT-proBNP after patients receiving 24 week treatment(24 week)
- Comprehensive cause mortality after patients receiving 52 week treatment(24 week)
- EQ-5D Questionnaire score after patients receiving 24 week treatment(24 week)
- Change of NYHA grading after patients receiving 24 weeks treatment(24 week)
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