The Effect of Carvedilol Rapid Up-Titration in Patients With Heart Failure With Reduced Ejection Fraction (Biomolecular and Clinical Study on IL-6, TNF-α, NT-ProBNP, MDA, LVEF, 6MWT, and KCCQ)
试验速览
- 阶段
- 4 期
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Improvements of Biomolecular Parameters
研究概览
简要总结
Guidelines-directed medical therapy has improved dramatically outcomes in heart failure with reduced ejection fraction (HFrEF) patients. Beta-blockers have the most beneficial effects on all caused mortality and rehospitalization on HFrEF, but unfortunately, since the discovery of beta-blocker therapy in HFrEF, there was no change in the way of titration, start low go slow, which resulted in difficulties in reaching optimal doses for some patients.
详细描述
This study is a randomized controlled trial, single-center study in HFrEF patients, that held in Universitas Sebelas Maret Hospital, Central Java, Indonesia. The investigators divided 26 HFrEF patients consecutively into two groups, the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks. Every patient will be checked for IL-6, TNF-α, NT-ProBNP, MDA, left ventricular Ejection Fraction, six minutes walking test, and Kansas City Cardiomyopathy Questionnaire on day 1, pre-discharge, and one month after hospitalization. The study was approved by the university ethics committee. The clinical parameters evaluated at admission were analyzed using variable comparative with Shapiro Wilk or one-way ANOVA, with three intervals analysis using repeated ANOVA (p<0.05).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patient, Care Provider and Investigator didn't know about dose of carvedilol and grouping of the patient.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute heart failure patient with reduced ejection fraction in Universitas Sebelas Maret Hospital with naive betablocker therapy
- •Age >18 years old
- •Initial Heart Rate > 50 bpm
排除标准
- •Cardiogenic Shock
- •Septicaemia
- •High degree AV Block or on pace maker
- •History of beta blocker intolerance
- •Reactive Pulmonary disease
- •Severe Peripheral artery disease
- •Creatinine level > 2.5 mg/dl
- •Potassium serum >5 mmol/L
研究组 & 干预措施
UpTitration
the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively
干预措施: Carvedilol (Drug)
Control
And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks
干预措施: Carvedilol (Drug)
结局指标
主要结局
Improvements of Biomolecular Parameters
时间窗: 1 month
IL-6 in pg/ml, TNF-α in pg/ml, NT-ProBNP in pg/ml, Malondyaldehide nmol/ml
Improvements of Clinical Parameters
时间窗: 1 month
Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition) and 6 Minutes Walking Test in meters
Improvements of Echocardiography Parameters
时间窗: 1 month
LVEF
次要结局
- Major Adverse Cardiac Events(1 month)
研究者
dr. Habibie Arifianto Sp.JP(K)., M.Kes., FIHA
Principal Investigator
Universitas Sebelas Maret