Comparative Effects of Single Versus Twice-Daily Ramipril Dosing on Renal Function in Patients With Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction: Evaluation of Plasma Renin Activity, Malondialdehyde, Interleukin-6, Albuminuria, and Cystatin C
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Plasma Renin Activity (PRA)
研究概览
简要总结
This study compares the effects of once-daily versus twice-daily ramipril dosing on renal function in chronic kidney disease (CKD) patients with heart failure with reduced ejection fraction (HFrEF). Outcomes include changes in plasma renin activity, malondialdehyde, interleukin-6, albuminuria, and cystatin C after 30 days of therapy.
详细描述
Chronic kidney disease (CKD) frequently coexists with heart failure with reduced ejection fraction (HFrEF), characterized by neurohormonal activation, inflammation, oxidative stress, and progressive renal deterioration. Activation of the renin-angiotensin-aldosterone system (RAAS) contributes significantly to both renal and cardiac dysfunction. Ramipril, an ACE inhibitor, is widely recommended for CKD with albuminuria and HFrEF. However, discrepancies exist in guidelines regarding once-daily versus twice-daily administration. These differences may influence RAAS suppression effectiveness and patient adherence.
This randomized, double-blind, parallel assignment clinical trial investigates the impact of once-daily (10 mg every 24 hours) versus twice-daily (5 mg every 12 hours) ramipril dosing on renal biomarkers in CKD patients with HFrEF. Outcomes include plasma renin activity (PRA), malondialdehyde (MDA), interleukin-6 (IL-6), albuminuria, and cystatin C measured over a 30-day treatment period. The study aims to provide scientific evidence to support optimal ramipril dosing strategies that improve renal outcomes among patients with CKD and reduced ejection fraction heart failure.
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, Outcomes Assessor)
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
- •Female or Male with age >18 years old
- •Patients with a diagnosis of CKD stage 3-5 non-dialysis with low ejection fraction heart failure (ejection fraction < 40%)
排除标准
- •Receiving hemodialysis therapy
- •History of intolerance to ACE inhibitors
- •Refractory hyperkalemia
- •Pregnancy
- •History of angioedema to ACE inhibitors
- •Receiving sacubitril-valsartan therapy
- •Receiving ARB therapy
- •Hypotension with blood pressure <90/60, or patients in shock.
研究组 & 干预措施
Once-Daily Ramipril
Participants receive ramipril 10 mg once daily for 30 days
干预措施: Ramipril (Drug)
Twice-Daily Ramipril
Participants receive ramipril 5 mg twice daily for 30 days
干预措施: Ramipril (Drug)
结局指标
主要结局
Change in Plasma Renin Activity (PRA)
时间窗: 30 days
Change in plasma renin activity from baseline to day 30.
Change in Malondialdehyde (MDA)
时间窗: 30 days
Change in plasma MDA levels as a biomarker of oxidative stress
Change in Interleukin-6 (IL-6)
时间窗: 30 days
Change in serum IL-6 levels as a marker of systemic inflammation
Change in Albuminuria
时间窗: 30 days
Change in albumin-creatinine ratio (ACR) from baseline to day 30
Change in Cystatin C
时间窗: 30 days
Change in serum cystatin C levels as a marker of glomerular filtration
次要结局
- Change in Serum Creatinine(30 days)
- Change in Estimated Glomerular Filtration Rate (eGFR)(30 days)
- Change in Blood Pressure (Systolic and Diastolic)(30 days)
- Incidence of Treatment-Related Adverse Events(30 days)
研究者
Evi Liliek Wulandari
Principal Investigator, Consultant Internist (Internal Medicine Specialist)
Universitas Sebelas Maret