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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Ramipril administered either as 10 mg once daily or 5 mg twice daily for 30 days
UNS Hospital
Kartasura, Central Java, Indonesia
RECRUITINGChange in Plasma Renin Activity (PRA)
Change in plasma renin activity from baseline to day 30.
Time frame: 30 days
Change in Malondialdehyde (MDA)
Change in plasma MDA levels as a biomarker of oxidative stress
Time frame: 30 days
Change in Interleukin-6 (IL-6)
Change in serum IL-6 levels as a marker of systemic inflammation
Time frame: 30 days
Change in Albuminuria
Change in albumin-creatinine ratio (ACR) from baseline to day 30
Time frame: 30 days
Change in Cystatin C
Change in serum cystatin C levels as a marker of glomerular filtration
Time frame: 30 days
Change in Serum Creatinine
Change in serum creatinine concentration from baseline to day 30, measured by standard hospital laboratory methods
Time frame: 30 days
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) from baseline to day 30, calculated using the CKD-EPI equation
Time frame: 30 days
Change in Blood Pressure (Systolic and Diastolic)
Change in clinic-measured systolic and diastolic blood pressure from baseline to day 30
Time frame: 30 days
Incidence of Treatment-Related Adverse Events
Number and type of adverse events considered related to ramipril during 30 day treatment period (e.g. hyperkalemia), graded by severity
Time frame: 30 days
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