NCT04448899已完成4 期
Effects of Ivabradine on Neopterin and NT-Pro BNP in Patients With Congestive Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neopterin
研究概览
简要总结
The aim of this study is to assess the efficacy of Ivabradine therapy in patients with congestive heart failure using the cardiac biomarkers NT-Pro BNP and Neopterin.
详细描述
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
- All participants have agreed to take part in this clinical study and provide informed consent
- A 3 months, prospective interventional study.
- Sixty ambulatory, clinically stable symptomatic patients with systolic chronic HF (≥ 4 weeks), on optimized standard medical therapy were consecutively included and randomly allocated to the ivabradine group (n=30) and non-ivabradine group (n=30).
- The baseline evaluation comprised physical examination, NYHA class, 12-lead electrocardi¬ography (ECG), Echocardiography, blood sampling for laboratory measurements, including NT-Pro BNP and Neopterin.
- Patients in the Ivabradine group were administered Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability.
- Patients were followed up after 1 week of initiation of ivabradine therapy then monthly till the end of the study.
- Peripheral venous blood samples were drawn between 8 and 9 am after a 30-min rest in the supine position. Serum samples were frozen at -80°C until assay.
- Levels of NT-Pro BNP and Neopterin were detected using ELISA kits as prescribed by manufacturer.
- Statistical tests appropriate to the study will be conducted to evaluate significance of results
- Results, conclusion, discussion and recommendations will be given
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)
盲法说明
double-blind study
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic HF, on optimized medical therapy according to European Society of Cardiol¬ogy guidelines, with LV ejection fraction (LVEF) < 35% according to the Simpson method, New York Heart Association (NYHA) class II-III, and sinus rhythm and resting HR > 70/min were eligible for inclusion in the study.
排除标准
- •acute decompen¬sation (acute coronary syndromes and acute HF);
- •hemodynamically significant valve disease;
- •cer¬ebrovascular events during the previous 6 months;
- •dysfunctional prosthetic heart valve;
- •obstructive or non-obstructive cardiomyopathy; uncorrected congenital heart disease; active myocarditis;
- •a his¬tory of resuscitation from sudden death; an absence of stable sinus rhythm, severe arrhythmias; HR < 60 bpm; sick sinus syndrome; second-degree and third-degree atrioventricular block;
- •severe obesity (body mass index > 36 kg/m²);
- •established or sus¬pected pulmonary diseases (vital capacity < 80% or forced expiratory volume in 1 s < 80% of age spe¬cific and sex-specific reference values);
- •hemoglobin ≤ 11 g/dL;
- •treatment with non-dihydropyridine calcium-channel blockers, class I antiarrhythmic agents, strong inhibitors of cytochrome P450-3A4, or QT interval-prolonging medications;
- •acute and chronic kidney failure;
- •pregnancy; hypo- and hy¬perthyroidism or acute infections.
研究组 & 干预措施
Ivabradine
Active Comparator
Patients administered Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability.
Patients were followed up after 1 week of initiation of ivabradine therapy then monthly till the end of the study.
干预措施: Ivabradine Oral Tablet (Drug)
Control
Placebo Comparator
Patients administered a placebo twice daily. Patients were followed up after 1 week of initiation of the study then monthly till the end of the study.
干预措施: Blacebo plus standard treatment (Drug)
结局指标
主要结局
Neopterin
时间窗: three months
Serum Neopterin (nmol/L)
NT-Pro BNP
时间窗: three months
Serum BNP (pg/ml)
次要结局
- Heart Rate(Three Months)
研究者
Rehab Werida
Principal Investigator
Damanhour University
研究点 (1)
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